# K982248: Howmedica Asymmetric Stem Vitalock Cluster & Spiked Shells, and Acetabular Shells with Mesh Ingrowth Surface with Peri-a

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Aug 31, 1998 after 66 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930223 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971206: Meridian ST Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating, Howmedica Corp. (1998) Summary page 1.
- K955871: Howmedica Asymmetric Stem Femoral Component, Howmedica Corp. (1996) Summary page 1.
- K933102: Howmedica Acetabular Shell W/Screw Holes, Howmedica Corp. (1994) Summary page 1.
- K953664: Vitalock Spiked Acetabular Shell, Howmedica Corp. (1995) Summary page 1.
- K973163: Acetabular Shells with Mesh Ingrowth Surface, Howmedica Corp. (1997). Our OCR of the scanned summary read K373163, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Mesh Ingrowth Shells”.

## Indications for use
The Howmedica® Asymmetric Stem, Vitalock® Cluster & Spiked Shells, and Mesh Ingrowth Shells with Peri-Apatite™ Coating are intended to be used in the primary uncemented reconstruction of the proximal femur and acetabulum, respectively.

Source page: https://510kreport.com/device/K982248
Methodology: https://510kreport.com/methodology