# K102019: Restoration Acetabular Wedge Augments

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics
- Decided: Mar 3, 2011 after 227 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
Longest line of descent: 2 generations back to K001471 (2000). 5 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061067: Trabecular Metal Acetabular Augments, Zimmer Trabecular (2006) Summary page 1.
- K971422: Osteonics Acetabular Wedge System, Osteonics Corp. (1997) Summary page 1.

## Most influential descendants
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own
- K193429: Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (2020), 6 descendants of its own

## Recalls of this device
- Aug 15, 2014 · Class II · Z-1633-2015: The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

## Indications for use
The indications for use of the Restoration Acetabular Wedge Augments: General Indications for Total Hip Replacement Components: * Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. * Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. * Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. * Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulumn. Indications Specific to the Acetabular Wedges: *As an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies. Acetabular Augments are intended for cementless use only to the bone interface; and 2) are affixed to the mating cup using bone cement

Source page: https://510kreport.com/device/K102019
Methodology: https://510kreport.com/methodology