510(k) · Cleared
ClearedCoCr Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Jan 10, 2023 as substantially equivalent to K993259 (Sulzer Orthopedics, Inc., 2000) after a 642-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jan 10, 2023
- Review
- 642 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K955033 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 2 generations backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- 1 generation backK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- This deviceK211047 CoCr HeadZimmer GmbH · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −2 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| −1 | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | 3 |
| 0 (this device) | K211047 | CoCr Head | Zimmer GmbH | 2023 | — |
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 |
|---|---|---|---|
| * | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSummary page 4…Hip joint metal/polymer semi-constrained cemented prosthesis, JDI Predicate Device: CoCr Head, manufactured by Zimmer GmbH, K993259, cleared March 10th, 2000 Device Description: The Subject CoCr Heads are intended to b… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 4 other devices also cite its predicate K993259.
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. 2023, this device’s year, is highlighted.
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?
Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., theumatoid arthritis.
Failed previous surgery where pain, deformity, or dysfunction persists.
Revision of previously failed hip arthroplasty.
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/K211047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211047: CoCr Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211047
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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