(103 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as being designed and manufactured from patient imaging data, which is typical for patient-specific guides without necessarily involving AI/ML.
No
The device is described as "surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting." It is a surgical tool used to aid in a procedure, not a device that directly treats a disease or condition.
No
The device, ShapeMatch Cutting Guides, is described as patient-specific surgical instrumentation that assists surgeons in positioning total knee arthroplasty components and guiding bone marking for cutting. Its function is to aid in surgical procedures, not to diagnose medical conditions or diseases.
No
The device description explicitly states the ShapeMatch Cutting Guides are "single-use, disposable, cutting guides designed and manufactured from patient imaging data (MRI/CT)" and are "manufactured from polyoxymethylene". This indicates a physical, hardware component, not a software-only device. While software is used in the design process, the final device is a physical cutting guide.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The ShapeMatch Cutting Guides are physical surgical instruments used during surgery to guide bone cuts. They do not analyze or test any biological samples.
- The intended use is to assist in surgical procedures. The description clearly states their purpose is to help position components and guide bone marking/cutting during total knee arthroplasty.
- The device is a physical cutting guide. It's manufactured from polyoxymethylene and used as a tool in the operating room.
The information provided describes a surgical planning and guidance tool, not a device for diagnostic testing of biological samples.
N/A
Intended Use / 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.
Product codes
MBH, JWH, OOG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI/CT
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, intraoperatively
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K031729, K040267, K042993, K051146, K051380, K053514, K062037, K061251, K063423, K072575
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
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.(b)
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.
0
K122053 (1/2)
OCT
24
2012
510(k) Summary
| Sponsor | Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tammy Wharton
Senior Regulatory Affairs Specialist
OtisMed, Stryker Orthopaedics
1600 Harbor Bay Parkway, Suite 200
Alameda, CA 94502
Phone: (510) 995-4462 |
| Date Prepared: | September 27, 2012 |
| Proprietary Name: | ShapeMatch® Cutting Guides |
| Common Name: | Cutting Guide |
| Classification Name: | 21 CFR §888.3560
Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-
Constrained Cemented Prosthesis
21 CFR §888.3565
Knee joint patellofemorotibial metal/polymer porous-coated
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
1
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.
2
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use | |
| (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)
Division of Surgical, Orthopedic, and Restorative Devices |
| ------------- | ---------------------------------------------------------------------------------- |
|---|
| 510(k) Number | K122053 |
|---|---|
| --------------- | --------- |
Page 3