# K983226: Osteonics X Cemented Hip Stem Series

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Dec 4, 1998 after 80 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 2 cite it directly.
0 of 20 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) Osteonics® Omnifit® Plus Hip Stems: named in the summary without a submission number
- (no number) Osteonics® Omnifit®-C Hip Stems: named in the summary without a submission number
- (no number) Osteonics® ODC™ Hip Stems: named in the summary without a submission number
- (no number) Osteonics® ODC™ Plus Hip Stems: named in the summary without a submission number

## 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
- Nov 13, 2008 · Not classified · Z-0898-2009: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
- Nov 13, 2008 · Not classified · Z-0899-2009: Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

## Indications for use
The Osteonics® X Cemented Hip Stems Series are intended for single use in patients requiring either a Total Hip Replacement or Hemi- or Bipolar Hip Replacement. The Osteonics® X Cemented Hip Stem Series are intended to provide a variety of options as a means for the Orthopaedic Surgeon to obtain an implant-to-patient match designed to provide reproducible cemented hip arthroplasty when used in conjunction with the Osteonics® Femoral Bearings with C-Taper geometry specified in this submission. Indications: For use as a Bipolar or Hemi-Hip Replacement: Femoral head/neck fractures or non-unions. Aseptic necrosis of the femoral head. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other considerations for use as a Bipolar or Hemi-Hip Replacement: Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. Salvage of failed total hip arthroplasty. For use as a Total Hip Replacement: 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.

Source page: https://510kreport.com/device/K983226
Methodology: https://510kreport.com/methodology