# K082358: Smith & Nephew, Inc. Patient Matched Technology

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 25, 2008 after 99 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
428 later devices descend from it; 8 cite it directly.
3 of 429 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Smith & Nephew, Inc.'s distal femoral cutting blocks: named in the summary without a submission number
- (no number) Smith & Nephew, Inc.'s proximal tibial cutting blocks: named in the summary without a submission number

## Most influential descendants
- K093533: Zimmer Patient Specific Instruments System, Version 2.0 (2010), 404 descendants of its own
- K111492: Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific Instruments (2011), 314 descendants of its own
- K113666: Xia 3 Spinal System (2012), 251 descendants of its own
- K102795: Signature Planner; Signature Guides (2011), 99 descendants of its own
- K133350: Revere Stabilization System (2014), 93 descendants of its own

## Indications for use
Smith & Nephew's Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The Patient Matched Cutting Blocks are intended for use with existing Smith & Nephew, Inc. knee systems and their cleared indications for use. The Patient Matched Cutting Blocks are intended for single use only.

Source page: https://510kreport.com/device/K082358
Methodology: https://510kreport.com/methodology