# K151264: Restoration Anatomic Shell

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Orthopaedics
- Decided: Aug 10, 2015 after 89 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905258 (1991). 3 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142462: Restoration Anatomic Shell, Stryker Orthopaedics (2014) Summary page 4.
- K010170: Trident Porous Titanium Acetabular Component, Howmedica Osteonics Corp. (2001) Summary page 4.

## 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
- Apr 16, 2020 · Class II · Z-2091-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2088-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2086-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2099-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2087-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2096-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2095-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2089-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2085-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2098-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2084-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2093-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2097-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2094-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2090-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Apr 16, 2020 · Class II · Z-2092-2020: The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
- Jun 3, 2016 · Class II · Z-2281-2016: Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.

## Indications for use
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic 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 acetabulum. When used with MDM Liners Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Dislocation risks When used with Constrained Liner: The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability. The Restoration® Anatomic Shell is indicated for cementless use only.

Source page: https://510kreport.com/device/K151264
Methodology: https://510kreport.com/methodology