510(k) · Cleared
ClearedZimmer Anatomic II Hip Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jul 20, 2004 as substantially equivalent to K922071 (Zimmer, Inc., 1994) after an 83-day review. Its family tree reaches back 1 generation to 1994. 268 later devices descend from it.
- Decided
- Jul 20, 2004
- Review
- 83 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922071 (1994). 268 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK922071 Zimmer Anatomic Hip SystemZimmer, Inc. · 1994 · Recalled
- This deviceK041109 Zimmer Anatomic II Hip ProsthesisZimmer, Inc. · 2004
- Descendant · cites it directly · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- Descendant · 2 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
- Descendant · 3 generations on · 117 of its ownK093472 Trinity Acetabular SystemCorin USA · 2010 · Recalled
- Descendant · 4 generations on · 109 of its ownK110087 Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011
Showing 5 of 268 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 268 · See all- K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · cites it directly267descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 2 generations on198descendants
- K043079Bicontact Hip System with U-CapAesculap · 2004 · 2 generations on166descendants
- K093472Trinity Acetabular SystemCorin USA · 2010 · 3 generations on117descendants
- K110087Corin Trinity Acetbular System with Hxlpe LinersCorin USA · 2011 · 4 generations on109descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922071 | Zimmer Anatomic Hip System | Zimmer, Inc. | 1994 | 6 |
| 0 (this device) | K041109 | Zimmer Anatomic II Hip Prosthesis | Zimmer, Inc. | 2004 | — |
| +1 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| +2 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +2 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| +3 | K093472 | Trinity Acetabular System | Corin USA | 2010 | 1 |
| +4 | K110087 | Corin Trinity Acetbular System with Hxlpe Liners | Corin USA | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 14 | 0 |
| 2012 | 21 | 0 |
| 2013 | 20 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 15 | 0 |
| 2018 | 16 | 0 |
| 2019 | 14 | 0 |
| 2020 | 16 | 0 |
| 2021 | 19 | 0 |
| 2022 | 16 | 0 |
| 2023 | 16 | 0 |
| 2024 | 12 | 0 |
| 2025 | 21 | 0 |
| 2026 | 19 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.2 · 20 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 |
|---|---|---|---|
| * | K922071 | Zimmer Anatomic Hip System | 1994 |
What descends from it? (268)
See all 2681 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040191 | Bicontact Hip Stem and Femoral Head | 2004 | 267 |
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?
How does its category compare?
All LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The Zimmer Anatomic II Hip Prosthesis is indicated for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the fernoral head, and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
- Patients suffering from disability due to previous fusion.
- Patients with acute femoral neck fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041109 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041109: Zimmer Anatomic II Hip Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041109
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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