Call Customer Service at 781-982-7000 for Pricing and Ordering Information.

TKR Positioner, 24" & 30"

ProductID: 800-0141_800-0171
  • TKR Positioner, 24
  • TKR Positioner, 30
  • TKR Positioner
  • TKR Positioner
  • Custom Sterilization Tray
Customer Serivce
For product pricing and information, please call our Customer Service Team at 781-531-9164 or fill out the Request a Quote form.



This ball-track system for total knee replacements is a huge leap forward for the surgeon and patient alike. Ball joint at the heel of the leg holder places the operative leg in extension, flexion, tilt and rotation. Easy-to-use and completely rigid once locked. Eliminates the need for additional leg positioning devices, sandbags and gel-pads.

  • NEW Custom Sterilization Tray included with purchase
  • Track Locking Bracket securely locks the Base Plate to the table with two thumb screws
  • Locks in any position with a simple turn of the wrist
  • Smooth sliding motion for effortless leg positioning
  • Well leg lies flat – eliminating the need for well-leg positioners
  • All components are autoclavable
  • Required CamLoc Rail Clamp sold separately
  • Available in 24" (61 cm) & 30" (76 cm)
  • Includes (1) TKR Boot Liner

Required Accessory
CamLoc Rail Clamp

Optional Accessory
TKR Boot Liners


Download IFU pdf 

  TKR Positioner,  24” (61 cm)  800-0141
  TKR Positioner,  30”
(76 cm)  800-0171

Replacement Liners
TKR Boot Liners, 12/cs  800-0146

INTENDED USE 
Intended use is to allow surgeon to position operative leg in multiple positions (extension, flexion, tilt, and rotation) during total knee replacement surgery. The intended users of this device are medical professionals within hospitals and surgery centers.

 GENERAL INFORMATION
  • Product not made with Natural Rubber Latex
  • Device supports 500 lbs (227 kg) proportional patient load (6’4” (193 cm) tall patient per 99% human body model)
  • Product warranty covers product from manufacturing defects for period of 2 years
  • If damaged in shipping, call Customer Service at (888) 724-8763 or (781) 982-7000 to obtain Return Material Authorization number. For product warranty issues, contact Customer Service.
  • CE marked medical device according to MDR (EU) 2017/745
  • Product is maintenance-free, check product condition before next use
  • Life of device is 3 years under normal use
  • Store device between -4°F to +86°F (-20°C to +30°C)
  • All components must be cleaned before and after use. See cleaning instructions below.
  • All components need to be steam sterilized. See sterilization instructions below.

INSTRUCTIONS
Become familiar with patient positioning device’s features before use with patient. Always practice on a nurse, physician, or appropriate volunteer prior to using clinically.


   
Set Up and Use of TKR Positioner

  1.  Drape the surgical table. Choose Standard CamLoc Clamp (sold separately) to use with 1-2 drapes or Large CamLoc Clamp for 3-5 drapes.
  2. Attach (A) CamLoc Clamp to rail. Then flip (B) Locking Lever right or left to secure. (DO NOT ATTACH OVER THE NOTCHES WITHIN THE SIDE RAIL).
  3. Slide (C) Track System Crossbar into CamLoc Clamp. Securely tighten Track System Crossbar by turning (D) CamLoc Clamp Star Knob clockwise. 
  4. Slide (E) Base Plate into (F) Cross Support Bar making sure its flush. Tighten two (G) Star Knobs by turning clockwise.
  5. Insert Plastic Slide (K) within opening under Adjustable Slide Block (H), with notched side up. Make sure handle is rotated until it stops (do not tighten) before sliding on to Base Plate. Handle should be in 12:00 position (see Figure 5). Depress button and pull handle to adjust as needed. Slide on to track system while holding Plastic Slide up close to Adjustable Slide Block. WARNING! Only adjust adjustable slide block lever when it is on track.
  6. Place (I) Adjustable Boot Ball into track system’s Adjustable Slide Block
  7. Line boot with our Sterile Disposable Boot Liner 800-0146 (12/cs, sold separately)
  8. Prep and position patient, turn (J) Slide Block Locking Handle right to lock into desired position

GENERAL SPECIFICATIONS
Device Dimensions (maximum) 
Single-person installation.


800-0141  TKR, 24” (61 cm)
Length: 23.7”+/- 0.5” (61 cm +/- 1 cm)
Width: 7.5” +/- 0.5” (19 cm +/- 1 cm)
Height: 8.1” +/- 0.5” (20 cm +/- 1 cm)
Net Weight: 9 +/- 0.5 lbs. (4 kg +/- .22 kg)
Gross Weight: 12.5 +/- 0.5 lbs. (5.6 kg +/- .22 kg)

Net Weight: 9 +/- 0.5 lbs. (4 kg +/- .22kg)?Gross Weight: 12.5 +/- 0.5 lbs. (5.6 kg +/- .22kg)

800-0171  TKR, 30” (760 mm)
Length: 29.7” +/- 0.5” (76 cm +/- 1 cm)
Width: 7.5” +/- 0.5” (19 cm +/- 1 cm)
Height: 8.1” +/- 0.5” (20 cm +/- 1 cm)
Device Weight: 10 +/- 0.5 lbs. (4.5 kg +/- .22 kg)
Gross Weight: 14.5 +/- 0.5 lbs. (6.5 kg +/- .22 kg) 

COMPONENT OVERVIEW
TKR Positioner, 24” (61 cm) or 30” (76 cm), is a surgical accessory that allows the surgeon to position operative leg during total knee replacement surgery.

800-0141-TRAY  TKR Sterilization Tray, 24” (61 cm) (included with 800-0141 purchase)
800-0171-TRAY 
TKR Sterilization Tray, 30” (76 cm) (included with 800-0171 purchase)

Required Accessories: CamLoc Rail Clamp and TKR Boot Liners sold separately. 

CamLoc Clamp:?800-0271  For use with 1-2 drapes?800-0271-L  For use with 3-5 drapes
CamLoc Clamp:?800-0271  For use with 1-2 drapes?800-0271-L  For use with 3-5 drapes
CamLoc Clamp:?800-0271  For use with 1-2 drapes?800-0271-L  For use with 3-5 drapes
CamLoc Rail Clamp:
800-0271  For use with 1-2 drapes
800-0271-L  For use with 3-5 drapes

US: 0.374” x 1.122” (9.5 mm x 28.5 mm) PN# 800-0271 or 800-0271-L     
Denyer: 0.236” x 1.496” (6 mm x 38 mm) PN# 800-0271-DEN 
Europe: 0.394” x 0.984” (10 mm x 25 mm ) PN# 800-0271-EU
Eschmann (UK): 0.236” x 1.260” (6 mm x 32 mm) PN# 800-0271-UK
Japan: 0.354” x 1.260” (9 mm x 32 mm ) PN# 800-0271-JPN
Swiss: 0.394” x 1.181” (10 mm x 30 mm ) PN# 800-0271-SWISS

Replacement Liners
800-0146   TKR Boot Liners, 12/cs  

DISPOSAL
  • General - Prevent infection by cleaning and disinfecting product before disposal
  • Packaging - Dispose packaging material via household waste according to national requirements
  • SchureMed accepts back used or retired products - or dispose of product in accordance with national requirements


PRODUCT USE WARNINGS 
WARNING! 

Maximum load should not exceed appropriate proportion of a patient weighing 500 lbs. (227 kg). Use care with low-maximum load capacity surgical tables that accessory rails are not overloaded.
  

WARNING! 

Hazards result from incorrect use. Strictly follow instructions for use with your Operating Table system.


WARNING! 
Do not reuse device if there are obvious signs of damage or functional issues. Consult manufacturer before reusing.

  

WARNING!
 
Only adjust adjustable slide block lever when it is on the track.

Hand and Washer Machine Cleaning Instructions
  • Clean TKR Positioner thoroughly before using (before sterilization) and after each use
  • Recommended cleaning products: (All solutions should be used in accordance with manufacturer’s instructions)
    - Enzymatic neutral pH detergent solution
    - (Enzymatic cleaners are compatible with metal devices/instruments and are preferred)
    - Non-enzyme, hydrogen peroxide based solution
    - Coverage Plus NPD One Step Cleaner, Disinfectant & Deodorizer Concentrate
  • Disassemble TKR Positioner into separate parts for cleaning:
    - Boot Ball
    - Mounting Plate with Clamp
    - Base Plate with Track
    - Slide Block with Handle
    - Plastic Slide
Hand Cleaning
  • Scrub each piece with a soft, plastic scrub brush and a recommended cleaning solution (see above)
  • Rinse all parts thoroughly to remove any chemical residue
  • Wipe each part completely dry with a clean, lint-free cloth
Washer Cleaning
  • Put through washer/decontaminator according to manufacturer’s instruction (Select cycle that does not included lubrication)
  • Prepare for sterilization (device must be cleaned before sterilization)
  • See sterilization instructions below

*Based on information provided by the Healthcare Infection Control Practices Advisory Committee (HICPAC), the Center for Disease Control (CDC), the National Center for Biotechnology Information (NCBI) and the U.S. National Library of Medicine.


STEAM STERILIZATION

Sterilization Tray w/Lid
(Outside View)

24” Tray Dimensions
  • 26.5”L x 10.5”W x 6.75”D (67 cm x 27 cm x 17 cm)
  • Weight: 7.9 lbs. (3.6 kg)
30” Tray Dimensions
  • 31.25”L x 10.5”W x 6.75”D  (79 cm x 27 cm x 17 cm)
  • Weight: 8.7 lbs. (3.9 kg)

Sterilization Tray 
(Inside View)


Sterilization Tray Component Placement  

Place following parts in dedicated slots:
  1. Place Base Plate upright  (as shown)
  2. Place TKR Boot within black outline for exact placement
  3. Place parts vertically in slots

Steam Sterilization Procedure

Wrap using envelope method or accepted wrap method at your facility.

Pre-Vacuum
Wrapped Instruments
Exposure Time at 270°F: (132°C) 4 minutes
Drying Time: 40 minutes


USER NOTICE
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

 IFU-800-0141_0171 REV 3.10

  Basic UDI-DI: 081001460F0015DV

Latest Revision: 2022-01

eIFU Language Versions
To download and print the Instructions for Use, please click here.

Symbol Glossary


Manufacturer

SchureMed (081001460)
452 Randolph Street, Abington, MA 02351 USA 
Toll Free ( 888 ) 724-8763  |  Ph (781) 982-7000
Fax (781) 982-7001  |  orders@schuremed.com


Authorized Representative
Emergo Europe, Prinsessegracht 20, 2514 AP The Hague, The Netherlands 

Available Combo Deals