# K071082: Stryker Modular Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 13, 2007 after 149 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Profemur® Total Hip Modular Neck System: named in the summary without a submission number
- (no number) Secur-Fit HA Stem: named in the summary without a submission number
- (no number) Accolade C and TMZF HA Stems: named in the summary without a submission number
- (no number) Citation TMZF HA Stem: named in the summary without a submission number

## Most influential descendants
- K130149: U2 Hip System, Expanded Indications for Use (2013), 0 descendants of its own
- K092561: Rejuvenate Modular Stem (2009), 0 descendants of its own

## Indications for use
The indications for use of the total hip replacement prostheses include: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Correction of functional deformity; 4) Revision procedures where other treatments or devices have failed; and, 5) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The Stryker Modular Hip System is intended for cementless use only.

Source page: https://510kreport.com/device/K071082
Methodology: https://510kreport.com/methodology