# K921308: HG Multilock Hip Prosthesis W/ TI-Nidium

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Feb 22, 1994 after 705 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
472 later devices descend from it; 3 cite it directly.
1 of 473 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K964769: Versys Hip System--Fiber Metal Taper Hip Prosthesis (1997), 363 descendants of its own
- K980711: Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating (1998), 309 descendants of its own
- K030733: Mayo Conservative Hip Prosthesis, Model 8026 Series (2003), 296 descendants of its own
- K040191: Bicontact Hip Stem and Femoral Head (2004), 267 descendants of its own
- K001277: Triflange Acetabular Cup System (2000), 213 descendants of its own

## Recalls of this device
- Oct 11, 2013 · Class II · Z-1026-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag

Source page: https://510kreport.com/device/K921308
Methodology: https://510kreport.com/methodology