# K112556: Adm and Adm/MDM Duration Inserts, Adm and Adm/MDM X3 Inserts

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Sep 28, 2011 after 26 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
Longest line of descent: 2 generations back to K010170 (2001). 4 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072020: Restoration Adm System, Howmedica Osteonics Corp. (2007) Summary page 2.
- K093644: Restoration Adm System X3 Acetabular, Howmedica Osteonics Corp. (2009) Summary page 2.
- K103233: Modular Dual Mobility Liner, X3 Acetabular Insert, Howmedica Osteonics Corp. (2011) Summary page 2.

## Most influential descendants
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own
- K233498: Stryker Orthopaedics Hip Systems Labeling Update (2023), 4 descendants of its own
- K243784: Stryker Orthopaedics Hip Devices Labeling Update (2025), 2 descendants of its own
- K220495: SignaSure Dual Mobility System (2023), 1 descendant of its own
- K261624: Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component (2026), 0 descendants of its own

## Recalls of this device
- Sep 6, 2011 · Not classified · Z-0931-2012: As part of Stryker's quality process, a packaging discrepancy was identified in specific lots of Stryker's Duration packaging.

## Indications for use
The indications for use for total hip arthroplasty 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 trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. 6) Dislocation risks The ADM and MDN4 Systems are intended for cementless use only.

Source page: https://510kreport.com/device/K112556
Methodology: https://510kreport.com/methodology