510(k) · Cleared
ClearedInsignia Hip Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Orthopaedics · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Aug 16, 2021 as substantially equivalent to K103479 (Stryker Corp., 2011) and 5 other predicates after a 74-day review. Its family tree reaches back 18 generations to 1994. 7 later devices descend from it.
- Decided
- Aug 16, 2021
- Review
- 74 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 18 generations to K941847 (1994). 198 ancestors in all, the oldest K810258 (1981). 7 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 14 generations between
- 3 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 2 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- 1 generation backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- This deviceK211703 Insignia Hip StemStryker Orthopaedics · 2021
- Descendant · cites it directly · 6 of its ownK220731 Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022
- Descendant · 2 generations on · 4 of its ownK233498 Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · 3 generations on · 2 of its ownK243784 Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
- Descendant · 3 generations on · 0 of its ownK261624 Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · Recalled
- Descendant · cites it directly · 0 of its ownK250375 Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG · 2025
Show all 18 generations
- Root · 18 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 17 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 16 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 15 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 14 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 13 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 12 generations backK060918 Excia Total Hip System 12/14 Trunnion with Ceramic HeadAesculap, Inc. · 2006
- 11 generations backK062684 Excia Total Hip System 36MM Ceramic HeadAesculap, Inc. · 2006
- 10 generations backK082991 Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc. · 2008
- 9 generations backK083495 Modification to: Metha Hip SystemAesculap Implant Systems, Inc. · 2009
- 8 generations backK090845 Apex Arc Hip StemOmni Life Science, Inc. · 2010 · Recalled
- 7 generations backK111193 Apex Arc Hip StemOmni Life Science, Inc. · 2011
- 6 generations backK113242 Apex Arc Hip StemOmni Life Science, Inc. · 2012
- 5 generations backK123991 Depuy Corail Amt Hip ProsthesisDepuy France S.A.S. · 2013 · Recalled
- 4 generations backK150862 DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc. · 2015 · Recalled
- 3 generations backK170339 Summit Hip SystemDePuy Orthopaedics, Inc. · 2018
- 2 generations backK193398 Summit DuoFix HA CoatingDePuy Orthopaedics, Inc. · 2020
- 1 generation backK202472 ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc. · 2020
- This deviceK211703 Insignia Hip StemStryker Orthopaedics · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker · 2022 · cites it directly6descendants
- K233498Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
- K243784Stryker Orthopaedics Hip Devices Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025 · 3 generations on2descendants
- K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026 · 3 generations on0descendants
- K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −17 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −16 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −15 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −14 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −13 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −12 | K060918 | Excia Total Hip System 12/14 Trunnion with Ceramic Head | Aesculap, Inc. | 2006 | — |
| −11 | K062684 | Excia Total Hip System 36MM Ceramic Head | Aesculap, Inc. | 2006 | — |
| −10 | K082991 | Biolox Delta Ceramic Femoral Head | Aesculap Implant Systems, Inc. | 2008 | — |
| −9 | K083495 | Modification to: Metha Hip System | Aesculap Implant Systems, Inc. | 2009 | — |
| −8 | K090845 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2010 | 2 |
| −7 | K111193 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2011 | — |
| −6 | K113242 | Apex Arc Hip Stem | Omni Life Science, Inc. | 2012 | — |
| −5 | K123991 | Depuy Corail Amt Hip Prosthesis | Depuy France S.A.S. | 2013 | 1 |
| −4 | K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 | 1 |
| −3 | K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018 | — |
| −2 | K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020 | — |
| −1 | K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020 | — |
| 0 (this device) | K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021 | — |
| +1 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022 | — |
| +2 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +3 | K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
| +3 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026 | 2 |
| +1 | K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 2 | 0 |
| 1987 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 20 | 0 |
| 1995 | 13 | 0 |
| 1996 | 15 | 0 |
| 1997 | 8 | 0 |
| 1998 | 8 | 0 |
| 1999 | 5 | 0 |
| 2000 | 20 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 9 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 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? (6)
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 5…, porous uncemented Legally Marketed Primary Predicate Devices to Which Substantial Equivalence is Claimed: • Accolade II Hip Stem (K103479, K120578) Legally Marketed Additional Predicate Devices Used to Support Substantial Equivalence: • Omnifit HFx (K031744… | 2011 |
| * | K120578 | Accolade II Hip StemSummary page 5…uncemented Legally Marketed Primary Predicate Devices to Which Substantial Equivalence is Claimed: • Accolade II Hip Stem (K103479, K120578) Legally Marketed Additional Predicate Devices Used to Support Substantial Equivalence: • Omnifit HFx (K031744)… | 2012 |
| * | K031744 | Omnifit HFX Hip Stem SeriesSummary page 5…aimed: • Accolade II Hip Stem (K103479, K120578) Legally Marketed Additional Predicate Devices Used to Support Substantial Equivalence: • Omnifit HFx (K031744) • Actis Hip Stem (K202472, K160907, K150862) Device Description: The Insignia Hip Stem is a sterile, single-use device… | 2003 |
| * | K202472 | ACTIS Duofix Hip ProsthesisSummary page 5…em (K103479, K120578) Legally Marketed Additional Predicate Devices Used to Support Substantial Equivalence: • Omnifit HFx (K031744) • Actis Hip Stem (K202472, K160907, K150862) Device Description: The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fix… | 2020 |
| * | K160907 | DePuy Actis DuoFix Hip ProsthesisSummary page 5…79, K120578) Legally Marketed Additional Predicate Devices Used to Support Substantial Equivalence: • Omnifit HFx (K031744) • Actis Hip Stem (K202472, K160907, K150862) Device Description: The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fixation int… | 2016 |
| * | K150862 | DePuy Actis Duofox Hip ProsthesisSummary page 5…78) Legally Marketed Additional Predicate Devices Used to Support Substantial Equivalence: • Omnifit HFx (K031744) • Actis Hip Stem (K202472, K160907, K150862) Device Description: The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fixation into a prepa… | 2015 |
What descends from it? (7)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 51 of the 197 ancestors have a recall of any class.
- Of its descendants, K220731 (Stryker, 2022) has gone furthest, with 6 descendants of its own.
- 9 other devices also cite its predicate K103479.
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. 2021, this device’s year, is highlighted.
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?
Hip Arthroplasty Indications: Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure. Correction of functional deformity Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with…
Read the full statement (181 words)
Hip Arthroplasty Indications:
Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
Correction of functional deformity
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:
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.
Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components:
When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks
Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.
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/K211703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211703: Insignia 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/K211703
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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