# K952970: Howmedica Femoral & Proximal Tibial Modular Replacement Sytesm

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jan 17, 1996 after 204 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043547: Compress Segmental Femoral Replacement System (2005), 11 descendants of its own
- K062998: Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug) (2007), 10 descendants of its own
- K112905: Compress (R) Segmental Humeral Replacement System (2012), 5 descendants of its own
- K173411: Comprehensive Segmental Revision System (SRS) (2018), 2 descendants of its own
- K080330: Segmental Distal Femoral Components and Proximal Femoral Bodies with a Compress Female Taper (2008), 2 descendants of its own

## Recalls of this device
- Nov 15, 2007 · Not classified · Z-0919-2008: Curvature Discrepancy --The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
- Nov 15, 2007 · Not classified · Z-0922-2008: Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
- Nov 15, 2007 · Not classified · Z-0927-2008: Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
- Nov 15, 2007 · Not classified · Z-0917-2008: Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
- Nov 15, 2007 · Not classified · Z-0918-2008: Curvature Discrepancy --The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
- Nov 15, 2007 · Not classified · Z-0920-2008: Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
- Nov 15, 2007 · Not classified · Z-0923-2008: Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
- Nov 15, 2007 · Not classified · Z-0924-2008: Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
- Nov 15, 2007 · Not classified · Z-0925-2008: Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
- Nov 15, 2007 · Not classified · Z-0926-2008: Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
- Nov 15, 2007 · Not classified · Z-0921-2008: Curvature Discrepancy -- The radius of curvature may be out of specification to varying degrees causing a discrepency in the stem curvature between trials and implants.
- Jan 7, 2003 · Not classified · Z-0587-03: Some components have disassociated post-operatively resulting in additional surgery to the patient.
- Jan 7, 2003 · Not classified · Z-0588-03: Some components have disassociated post-operatively resulting in additional surgery to the patient.

Source page: https://510kreport.com/device/K952970
Methodology: https://510kreport.com/methodology