SHAPEMATCH CUTTING GUIDE

K122053 · Stryker Corp. · MBH · Oct 24, 2012 · Orthopedic

Device Facts

• Record ID: K122053
• Device Name: SHAPEMATCH CUTTING GUIDE
• Applicant: Stryker Corp.
• Product Code: MBH · Orthopedic
• Decision Date: Oct 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2

Intended Use

The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The ShapeMatch Cutting Guides are intended for use with the CR, PS and CS components of the Triathlon® Knee System. The indications for use of the Triathlon Knee System when used with the ShapeMatch Cutting Guides are: General Total Knee Arthroplasty (TKR) Indications: - Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. - Post-traumatic loss of knee joint configuration and function. - Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. - Failed reconstruction procedures which did not involve the implantation of hardware on the condylar surfaces Additional Indications for Posterior Stabilized (PS): - Ligamentous instability requiring implant bearing surface geometries with increased constraint. - Absent or non-functioning posterior cruciate ligament. - Severe anteroposterior instability of the knee joint. The ShapeMatch Cutting Guides are intended for single use only.

Device Story

ShapeMatch Cutting Guides are patient-specific, single-use surgical instruments manufactured from MRI/CT imaging data. Used during total knee arthroplasty to assist surgeons in positioning components and marking bone for initial distal femoral and proximal tibial cuts. Guides establish reference for component orientation. Accessory Triathlon EM Universal Goniometer (stainless steel) used intra-operatively to verify component position by mating with saw slots. Device aids surgeon in achieving accurate alignment based on patient-specific anatomy; potentially improves surgical precision and implant longevity.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and software verification/validation per FDA guidance.

Technological Characteristics

Material: Polyoxymethylene (ASTM F1855). Accessory goniometer: Stainless steel (ASTM A564). Single-use, disposable. Patient-specific geometry derived from MRI/CT. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total knee arthroplasty due to painful, disabling joint disease (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of joint function, or moderate varus/valgus/flexion deformity. Additional indications for PS components include ligamentous instability, absent posterior cruciate ligament, or severe anteroposterior instability. Contraindicated for failed reconstructions involving hardware on condylar surfaces.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• Stryker® Patient Specific Cutting Guides (K110533)

Reference Devices

• Triathlon® Knee System (K031729, K040267, K042993, K051146, K051380, K053514, K062037, K061251, K063423, K072575)

Submission Summary (Full Text)

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K122053 (1/2)

OCT
24
2012

### 510(k) Summary

| Sponsor | Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tammy Wharton<br>Senior Regulatory Affairs Specialist<br>OtisMed, Stryker Orthopaedics<br>1600 Harbor Bay Parkway, Suite 200<br>Alameda, CA 94502<br>Phone: [phone] |
| Date Prepared: | September 27, 2012 |
| Proprietary Name: | ShapeMatch® Cutting Guides |
| Common Name: | Cutting Guide |
| Classification Name: | 21 CFR §888.3560<br>Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-<br>Constrained Cemented Prosthesis<br>21 CFR §888.3565<br>Knee joint patellofemorotibial metal/polymer porous-coated<br>uncemented prosthesis |

Legally Marketed Device to Which Substantial Equivalence is Claimed: Stryker® Patient Specific Cutting Guides, K110533

Device Description: The ShapeMatch Cutting Guides are single-use, disposable, cutting guides designed and manufactured from patient imaging data (MRI/CT). The cutting guides are used to aid the surgeon intra-operatively in making the initial distal femoral and the initial proximal tibial bone cuts during a total knee arthroplasty surgery. The cutting guides also establish the references for component orientations. The cutting guides are manufactured from polyoxymethylene per ASTM F1855.

The ShapeMatch Cutting Guides are intended for use with the Triathlon® Knee System (Cruciate Retaining (CR), Posterior Stabilized (PS) and Condylar Stabilizing (CS)) determined substantially equivalent via the following 510(k)s K031729, K040267, K042993, K051146, K051380, K053514, K062037, K061251, K063423, and K072575.

The accessory Triathlon® Extra-medullary (EM) Universal Goniometer is available for the surgeon to use intra-operatively to check the position of the femoral and tibial components. The goniometer mates with the saw slots on both the femoral and tibial guides for use in referencing the cuts with anatomic landmarks prior to resection of the bone. The accessory Triathlon® EM Universal Goniometer is made from Stainless Steel per ASTM A564.

Intended Use: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components

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intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

Indications: The ShapeMatch Cutting Guides are intended for use with the CR, PS and CS components of the Triathlon® Knee System. The indications for use of the Triathlon Knee System when used with the ShapeMatch Cutting Guides are:

## General Total Knee Arthroplasty (TKR) Indications:

- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function. .
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability.
- Failed reconstruction procedures which did not involve the implantation of hardware on . the condylar surfaces

### Additional Indications for Posterior Stabilized (PS):

- Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
- Absent or non-functioning posterior cruciate ligament. .
- Severe anteroposterior instability of the knee joint. ●

The ShapeMatch Cutting Guides are intended for single use only.

Summary of Technologies: Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the predicate device.

### Non-Clinical Testing:

Detailed software verification and validation were performed per FDA Guidance, "General Principles of Software Validation: Final Guidance for Industry and FDA Staff.

Clinical Testing: Not Applicable to validate changes.

Conclusion: The ShapeMatch Cutting Guides are substantially equivalent to the predicate device identified in this premarket notification.

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Image /page/2/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-0609, Silver Spring, MD 20993-0002. The address is likely for a specific department or division within the FDA.

OCT 24 2012

Howmedia Osteonics Corp. c/o Ms. Tammy Wharton Senior Regulatory Affairs Specialist OtisMed, Stryker Orthopaedics 1600 Harbor Bay Parkway, Suite 200 Alameda, CA 94502

Re: K122053

Trade/Device Name: ShapeMatch® Cutting Guides Regulation Number: 21 CFR 888.3565

Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis

Regulatory Class: Class II Product Code: MBH, JWH, OOG Dated: September 27, 2012 Received: October 3, 2012

Dear Ms. Wharton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Tammy Wharton

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K122053

Device Name: ShapeMatch® Cutting Guides

Indications for Use:

The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The ShapeMatch Cutting Guides are intended for use with the CR, PS and CS components of the Triathlon® Knee System. The indications for use of the Triathlon Knee System when used with the ShapeMatch Cutting Guides are:

General Total Knee Arthroplasty (TKR) Indications:

- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function. ●
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures . can be returned to adequate function and stability.
- Failed reconstruction procedures which did not involve the implantation of hardware on . the condylar surfaces

# Additional Indications for Posterior Stabilized (PS):

- Ligamentous instability requiring implant bearing surface geometries with . increased constraint.
- Absent or non-functioning posterior cruciate ligament. .
- Severe anteroposterior instability of the knee joint. .

The ShapeMatch Cutting Guides are intended for single use only.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| Over-The-Counter Use<br>(21 CFR 807 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Page 1 of 1 | (Division Sign-Off)<br>Division of Surgical, Orthopedic, and Restorative Devices |
|-------------|----------------------------------------------------------------------------------|
|-------------|----------------------------------------------------------------------------------|

| 510(k) Number | K122053 |
|---------------|---------|
|---------------|---------|

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