510(k) · Cleared
Recalled · Class II · 2013Accolade II Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Cleared on Mar 29, 2012 as substantially equivalent to K103479 (Stryker Corp., 2011) and 4 other predicates after a 31-day review. Its family tree reaches back 5 generations to 1994. 46 later devices descend from it. It has been recalled once.
- Decided
- Mar 29, 2012
- Review
- 31 days
- Class
- Class II
- Product code
- JDI
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 5 generations to K921308 (1994). 19 ancestors in all, the oldest K921301 (1994). 46 later devices descend from it, 9 citing it directly.
- Root · 5 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 4 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 3 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 2 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 1 generation backK103479 Novel Tapered Hip StemStryker Corp. · 2011
- This deviceK120578 Accolade II Hip StemHowmedica Osteonics · 2012
- Descendant · cites it directly · 30 of its ownK123604 Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · Recalled
- Descendant · cites it directly · 22 of its ownK122853 Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013
- Descendant · cites it directly · 21 of its ownK143085 Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip…Stryker Orthopaedics · 2015 · Recalled
- Descendant · cites it directly · 17 of its ownK153345 Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · Recalled
- Descendant · 2 generations on · 10 of its ownK171768 Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · Recalled
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K123604Abg Iii Monolithic Hip StemHowmedica Osteonics Corp. · 2013 · cites it directly30descendants
- K122853Novel Fit and Fill StemHowmedica Osteonics Corp. · 2013 · cites it directly22descendants
- K143085Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…Stryker Orthopaedics · 2015 · cites it directly21descendants
- K153345Stryker Orthopaedics Hip Systems Labeling UpdateStryker Orthopaedics · 2016 · cites it directly17descendants
- K171768Trident® II Acetabular SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −4 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −3 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −2 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −1 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| 0 (this device) | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | — |
| +1 | K123604 | Abg Iii Monolithic Hip Stem | Howmedica Osteonics Corp. | 2013 | 1 |
| +1 | K122853 | Novel Fit and Fill Stem | Howmedica Osteonics Corp. | 2013 | — |
| +1 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip… | Stryker Orthopaedics | 2015 | 2 |
| +1 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update | Stryker Orthopaedics | 2016 | 1 |
| +2 | K171768 | Trident® II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2017 | 12 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 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 JDI? 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 JDI device
- #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K103479 | Novel Tapered Hip StemSummary page 2…only and are intended for total and hemniarthroplasty procedures. Devices for which Substantial Equivalence is claimed: * Howmedica Osteonics Accolade HI System: K103479 " Howmedica Osteonics Restoration Modular System: KO013106 * Howmedica Osteonics Accolade TMZF: K994366, K020572 & K023… | 2011 |
| * | K013106 | 2 Piece Modular Hip StemSummary page 1…6A1-4V substrate material, Commercially Pure (CP) Titanium coating and Purefix hydroxylapatite (HA) coating identical to the previously cleared 2 Piece Modular Hip Stem (K0 13106). The Accolade 11 Femoral Hip Stem is available in 12 sizes ranging from size 0 through I I with two neck angles (1270 and 1320)… | 2002 |
| * | K994366 | TMZF Press Fit HA Stem and TMZF Press Fit Plus HA StemSummary page 2…laimed: * Howmedica Osteonics Accolade HI System: K103479 " Howmedica Osteonics Restoration Modular System: KO013106 * Howmedica Osteonics Accolade TMZF: K994366, K020572 & K023 102 Proposed Modification: The subject Accolade 11 Hip stems are compatible with additional acetabular componen… | 2000 |
| * | K020572 | Accolade TMZF HA 132 Degree Size 0 Hip StemSummary page 2…* Howmedica Osteonics Accolade HI System: K103479 " Howmedica Osteonics Restoration Modular System: KO013106 * Howmedica Osteonics Accolade TMZF: K994366, K020572 & K023 102 Proposed Modification: The subject Accolade 11 Hip stems are compatible with additional acetabular components. Summ… | 2002 |
| * | K023102 | Accolade TMZF Plus HA 127 Size 0 Hip StemSummary page 2…medica Osteonics Accolade HI System: K103479 " Howmedica Osteonics Restoration Modular System: KO013106 * Howmedica Osteonics Accolade TMZF: K994366, K020572 & K023 102 Proposed Modification: The subject Accolade 11 Hip stems are compatible with additional acetabular components. Summary of Tech… | 2002 |
What descends from it? (46)
See all 469 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123604 | Abg Iii Monolithic Hip Stem | 2013 | 30 |
| K122853 | Novel Fit and Fill Stem | 2013 | 22 |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use… | 2015 | 21 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | 2016 | 17 |
| K211703 | Insignia Hip Stem | 2021 | 7 |
| K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System | 2019 | 7 |
| K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &… | 2016 | 7 |
| K160895 | Initia Total Hip System & BIOCERAM AZUL (R) HEAD | 2016 | 2 |
| K140674 | Exactech Tapered Wedge Femoral Stem | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 25, 2013 | Class II | Z-0467-2014 | Packaging process control | Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 11 of the 19 ancestors have a recall of any class.
- Of its descendants, K123604 (Howmedica Osteonics Corp., 2013) has gone furthest, with 30 descendants of its own.
- 9 other devices also cite its predicate K103479.
How does its category compare?
All JDI devicesJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JDI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDI
59in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDI
1,644in 2025
MAUDE reports naming product code JDI, 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 | 3 | 81 | 26 | 696 |
| 2008 | 5 | 96 | 6 | 810 |
| 2009 | 3 | 65 | 3 | 964 |
| 2010 | 0 | — | 3 | 2,040 |
| 2011 | 2 | — | 5 | 3,160 |
| 2012 | 4 | 167 | 4 | 5,122 |
| 2013 | 3 | 176 | 11 | 5,206 |
| 2014 | 3 | 98 | 3 | 4,968 |
| 2015 | 3 | 190 | 1 | 4,906 |
| 2016 | 4 | 166 | 5 | 3,995 |
| 2017 | 1 | — | 5 | 6,135 |
| 2018 | 1 | — | 1 | 6,728 |
| 2019 | 2 | — | 1 | 7,407 |
| 2020 | 7 | 247 | 77 | 4,015 |
| 2021 | 3 | 162 | 0 | 3,170 |
| 2022 | 3 | 69 | 0 | 1,978 |
| 2023 | 2 | — | 0 | 1,635 |
| 2024 | 3 | 59 | 0 | 1,821 |
| 2025 | 1 | — | 1 | 1,644 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The indications for use of the total hip replacement prostheses 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; and, 5) Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.…
Read the full statement (141 words)
The indications for use of the total hip replacement prostheses 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; and,
5) Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indicationspecific to use ofAccolade II Fe moral Stems with compatible Howmedica Osgeonics Constrained Liners:
1. When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Accolade 11 Femoral Stems are intended for cementless use only and are intended for total and hemniarthroplasty procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120578: Accolade II 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/K120578
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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