# K072020: Restoration Adm System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 18, 2007 after 87 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- 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.
95 later devices descend from it; 10 cite it directly.
0 of 96 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) Trident® Acetabular System: named in the summary without a submission number
- (no number) Biomet Tri-Polar System: named in the summary without a submission number
- (no number) Plus Orthopaedics Ag Polarcup Dual Mobility System: named in the summary without a submission number
- (no number) UHR Bipolar System: named in the summary without a submission number

## Most influential descendants
- K083116: Versafit Cup Double Mobility System (2009), 59 descendants of its own
- K103233: Modular Dual Mobility Liner, X3 Acetabular Insert (2011), 52 descendants of its own
- K111572: Novae Sunfit TH Dual Mobility Acetabular Cup Model Sunfit TH (Metal-Back), Novae E TH Dual Mobility Acetabular Cup Model (2011), 27 descendants of its own
- K101336: E1 Avantage Head (2011), 24 descendants of its own
- K092265: Vesafitcup Double Mobility- Highcross Hxuhmwpe Liners (2010), 23 descendants of its own

## Recalls of this device
- Jun 3, 2011 · Not classified · Z-0194-2012: Stryker Orthopaedics has become ware that there is the potential for interpretation of the product labeling which may lead to an incorrect implant being used.

## 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; 5) Treatment of nonunion, femoral neck and trochanterie fractures of the proximal femur with head involvement that are unmanageable using other techniques. 6) Dislocation risks This acetabular cup is intended for cementless use only.

Source page: https://510kreport.com/device/K072020
Methodology: https://510kreport.com/methodology