510(k) · Cleared
Recalled · Class II · 2023Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Orthopedics, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Mar 10, 2000 as substantially equivalent to K983509 (Sulzer Orthopedics, Inc., 1999) after a 163-day review. Its family tree reaches back 2 generations to 1996. 326 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 10, 2000
- Review
- 163 days
- Class
- Class II
- Product code
- LPH
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955033 (1996). 326 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- 1 generation backK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- This deviceK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000
- Descendant · cites it directly · 285 of its ownK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- Descendant · 2 generations on · 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 · 3 generations on · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
- Descendant · cites it directly · 162 of its ownK022958 Total Hip Femoral Heads and LinersSmith & Nephew, Inc. · 2002 · Recalled
Showing 5 of 326 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 326 · See all- K022902Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002 · cites it directly285descendants
- K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 2 generations on267descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 2 generations on198descendants
- K043079Bicontact Hip System with U-CapAesculap · 2004 · 3 generations on166descendants
- K022958Total Hip Femoral Heads and LinersSmith & Nephew, Inc. · 2002 · cites it directly162descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| −1 | K983509 | Inter-OP Acetabular System - Durasul Acetabular Insert | Sulzer Orthopedics, Inc. | 1999 | — |
| 0 (this device) | K993259 | Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads | Sulzer Orthopedics, Inc. | 2000 | — |
| +1 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| +2 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| +2 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +3 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
| +1 | K022958 | Total Hip Femoral Heads and Liners | Smith & Nephew, Inc. | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 7 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 21 | 0 |
| 2012 | 22 | 0 |
| 2013 | 22 | 0 |
| 2014 | 10 | 0 |
| 2015 | 10 | 0 |
| 2016 | 15 | 0 |
| 2017 | 17 | 0 |
| 2018 | 18 | 0 |
| 2019 | 18 | 0 |
| 2020 | 18 | 0 |
| 2021 | 20 | 0 |
| 2022 | 23 | 0 |
| 2023 | 20 | 0 |
| 2024 | 16 | 0 |
| 2025 | 24 | 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 |
|---|---|---|---|
| * | K983509 | Inter-OP Acetabular System - Durasul Acetabular InsertSummary page 1…p™ Durasul™ Acetabular Inserts and CoCr Femoral Heads PRODUCT DESCRIPTION The Sulzer Orthopedics Inter-Op Durasul Acetabular Inserts were originally cleared via 510(k) K983509. The purpose of the present submission is to gain notice of substantial equivalence for line additions to these previously cleare… | 1999 |
What descends from it? (326)
See all 3265 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2023 | Class II | Z-1294-2023 | Under Investigation by firm | Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in… |
| Dec 17, 2014 | Class II | Z-1132-2015 | Package design/selection | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic… |
| Sep 4, 2012 | Class II | Z-0222-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K022902 (Smith & Nephew, Inc., 2002) has gone furthest, with 285 descendants of its own.
- 1 other device also cites its predicate K983509.
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 Inter-Op Durasul Acetabular Components and CoCr Femoral Heads are intended for use in treatment of the following:
1. Advanced joint destruction resulting from degenerative, posttraumatic or rheumatoid arthritis.
Fracture or avascular necrosis of the femoral head.
3. Failed previous surgery, e.g. osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty and total hip replacement.
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/K993259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993259: Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993259
Report an extraction error
Are you the manufacturer?
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