# K110533: Stryker Patient Specific Cutting Guide

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Corp.
- Decided: May 19, 2011 after 84 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: 1 generation back to K082358 (2008). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K082358: Smith & Nephew, Inc. Patient Matched Technology, Smith & Nephew, Inc. (2008) Summary page 1.

## Most influential descendants
- K122053: Shapematch Cutting Guide (2012), 2 descendants of its own
- 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 Stryker® Patient Specific 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. The Stryker® Patient Specific 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 Stryker Patient Specific 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 Stryker® Patient Specific Cutting Guides are intended for single use only.

Source page: https://510kreport.com/device/K110533
Methodology: https://510kreport.com/methodology