# K020572: Accolade TMZF HA 132 Degree Size 0 Hip Stem

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 4, 2002 after 11 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: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
66 later devices descend from it; 4 cite it directly.
0 of 67 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) TMZF® Press Fit HA Stem: named in the summary without a submission number

## Most influential descendants
- K103479: Novel Tapered Hip Stem (2011), 53 descendants of its own
- K120578: Accolade II Hip Stem (2012), 46 descendants of its own
- K123604: Abg Iii Monolithic Hip Stem (2013), 30 descendants of its own
- K122853: Novel Fit and Fill Stem (2013), 22 descendants of its own
- K143085: Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach (2015), 21 descendants of its own

## Recalls of this device
- Jan 6, 2009 · Not classified · Z-1358-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1684-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1361-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1356-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1359-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1354-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1360-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1355-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1363-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1357-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Jan 6, 2009 · Not classified · Z-1362-2009: Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.

## Indications for use
The subject hip stem is a single-use device intended for use in total hip replacement. It is intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty. This device is intended for use with any currently available Howmedica Osteonics acetabular component and V40™ femoral heads that can be mated with a 5° 40’ BG taper. Indications: Cementless primary hip surgery in cases of non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis, rtheumatoid arthritis, and correction of functional deformity. Treatment of nonunion, and femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. Revision procedures where other treatments or devices have failed.

Source page: https://510kreport.com/device/K020572
Methodology: https://510kreport.com/methodology