510(k) · Cleared
Recalled · 2009Accolade TMZF HA 132 Degree Size 0 Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Mar 4, 2002 after an 11-day review. The FDA summary names its predicate without a number. 66 later devices descend from it. It has been recalled 11 times.
- Decided
- Mar 4, 2002
- Review
- 11 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 11
- Predicates
- 0
66 later devices descend from it, 4 citing it directly.
- This deviceK020572 Accolade TMZF HA 132 Degree Size 0 Hip StemHowmedica Osteonics Corp. · 2002
- Descendant · cites it directly · 53 of its ownK103479 Novel Tapered Hip StemStryker Corp. · 2011
- Descendant · cites it directly · 46 of its ownK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
- Descendant · 2 generations on · 30 of its ownK123604 Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · Recalled
- Descendant · 2 generations on · 22 of its ownK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
- Descendant · 2 generations on · 21 of its ownK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K103479Novel Tapered Hip StemStryker Corp. · 2011 · cites it directly53descendants
- K120578Accolade II Hip StemHowmedica Osteonics · 2012 · cites it directly46descendants
- K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · 2 generations on30descendants
- K122853Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013 · 2 generations on22descendants
- K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics · 2015 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020572 | Accolade TMZF HA 132 Degree Size 0 Hip Stem | Howmedica Osteonics Corp. | 2002 | — |
| +1 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| +1 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
| +2 | K123604 | Abg Iii Monolithic Hip Stem | Howmedica Osteonics Corp. | 2013 | 1 |
| +2 | K122853 | Novel Fit and Fill Stem | Howmedica Osteonics Corp. | 2013 | — |
| +2 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip… | Stryker Orthopaedics | 2015 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | TMZF® Press Fit HA Stem Named without a submission number |
What descends from it? (66)
See all 664 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 6, 2009 | Not classified | Z-1358-2009 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K103479 (Stryker Corp., 2011) has gone furthest, with 53 descendants of its own.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (129 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020572 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020572: Accolade TMZF HA 132 Degree Size 0 Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020572
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026