# K971854: Osteolock Acetabular Shell System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Jul 30, 1997 after 71 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: 1 generation back to K903362 (1990). 4 ancestors in all.
216 later devices descend from it; 3 cite it directly.
0 of 221 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903362: Osteolock (TM) Acetabular Cup, Howmedica Corp. (1990) Summary page 2.
- K952397: Vitalock Solid Backed Acetabular Shell, Howmedica Corp. (1995) Summary page 2.
- K953664: Vitalock Spiked Acetabular Shell, Howmedica Corp. (1995) Summary page 2.
- K944592: Precision Osteolock Femoral Component, Howmedica Corp. (1995) Summary page 2.
- (no number) Osteonics’ Arc Deposition Hip Components: named in the summary without a submission number

## Most influential descendants
- K001448: Trident Acetabular Shells: PS-HA (2000), 150 descendants of its own
- K060437: Excia Total Hip System with U-Cap (2006), 90 descendants of its own
- K080584: Metha Short Stem Hip System (2008), 83 descendants of its own
- K001449: Trident Acetabular Shells: PS (2000), 69 descendants of its own
- K071916: Metha Hip System (2008), 68 descendants of its own

## Indications for use
The Osteolock™ Acetabular Shells are intended to be used to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. These components are designed to be press fit into the acetabulum. They do not achieve fixation by biological ingrowth.

Source page: https://510kreport.com/device/K971854
Methodology: https://510kreport.com/methodology