# K122053: Shapematch Cutting Guide

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: Oct 24, 2012 after 103 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K082358 (2008). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110533: Stryker Patient Specific Cutting Guide, Stryker Corp. (2011)

## Most influential descendants
- K193312: UNIKO PointCloud™ Knee Instruments (2020), 1 descendant of its own
- K240327: UNIKO PointCloud™ Knee Instruments (2024), 0 descendants of its own

## Recalls of this device
- Nov 8, 2012 · Class I · Z-1052-2013: With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing S

## 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.

Source page: https://510kreport.com/device/K122053
Methodology: https://510kreport.com/methodology