510(k) · Cleared
Recalled · 2011Accolade-J Hip Stem Series
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 Oct 9, 2003 after a 76-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 9, 2003
- Review
- 76 days
- Class
- Class II
- Product code
- MEH
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK032300 Accolade-J Hip Stem SeriesHowmedica Osteonics Corp. · 2003
- Descendant · cites it directly · 0 of its ownK162125 MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032300 | Accolade-J Hip Stem Series | Howmedica Osteonics Corp. | 2003 | — |
| +1 | K162125 | MALUC™ Total Hip Arthroplasty System | Surgtech, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | — | Accolade TMZF HA Hip Stems Named without a submission number | |
| * | — | Accolade TMZF HA Plus Hip Stems Named without a submission number | |
| * | — | Omnifit M-HA Hip Stems Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162125 | MALUC™ Total Hip Arthroplasty System | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2011 | Not classified | Z-2557-2011 | Employee error | Accolade TMZF Plus Hip Stems are being recalled due to grit blast media which was observed in the drive hole. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K162125 (Surgtech, Inc., 2017) has gone furthest, with 0 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 stems are single-use devices intended for cementless fixation. They are intended for primary reconstruction of the proximal feinur or revision total hip arthroplasty. These devices are intended for use with any currently available Nowniedica Osteonics acetabular component and V40° femoral heads labeled for use with V40° Titanium stems. ‘The indications for use remain identical to those of the predicate devices, and are restated here for…
Read the full statement (147 words)
The subject hip stems are single-use devices intended for cementless fixation. They are intended for primary reconstruction of the proximal feinur or revision total hip arthroplasty. These devices are intended for use with any currently available Nowniedica Osteonics acetabular component and V40° femoral heads labeled for use with V40° Titanium stems. ‘The indications for use remain identical to those of the predicate devices, and are restated here for ease of reference.
Non-in tlamnia to ry dege ne ra t i ve j o i n t d i sea se i nc 1ud i ng osteoar t 11r i t is and a vascu 1a 1- nec sos i s,
Rheumatoid arthritis,
Correction of functional deformity,
Revision procedures where other treatments or devices have failed,
Treatment of nonunion, and femoral neck and trochanteric fractures of the proxiinal feinur with head involvement that are unmanageable using other techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032300: Accolade-J Hip Stem Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032300
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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