510(k) · Cleared
ClearedInter-OP Acetabular System - Durasul Acetabular Insert
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 Feb 3, 1999 as substantially equivalent to K955033 (Intermedics Orthopedics, 1996) after a 119-day review. Its family tree reaches back 1 generation to 1996. 327 later devices descend from it.
- Decided
- Feb 3, 1999
- Review
- 119 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955033 (1996). 327 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK955033 Rim Flare Acetabular ComponentIntermedics Orthopedics · 1996
- This deviceK983509 Inter-OP Acetabular System - Durasul Acetabular InsertSulzer Orthopedics, Inc. · 1999
- Descendant · cites it directly · 326 of its ownK993259 Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 285 of its ownK022902 Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002
- Descendant · 3 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- Descendant · 3 generations on · 198 of its ownK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 166 of its ownK043079 Bicontact Hip System with U-CapAesculap · 2004
Showing 5 of 327 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 327 · See all- K993259Inter-OP Durasul Acetabular Inserts/Cocr Femoral HeadsSulzer Orthopedics, Inc. · 2000 · cites it directly326descendants
- K022902Smith & Nephew Hip SystemSmith & Nephew, Inc. · 2002 · 2 generations on285descendants
- K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 3 generations on267descendants
- K042344Excia Total Hip SystemAesculap, Inc. · 2005 · 3 generations on198descendants
- K043079Bicontact Hip System with U-CapAesculap · 2004 · 4 generations on166descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955033 | Rim Flare Acetabular Component | Intermedics Orthopedics | 1996 | — |
| 0 (this device) | 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 |
| +2 | K022902 | Smith & Nephew Hip System | Smith & Nephew, Inc. | 2002 | — |
| +3 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| +3 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| +4 | K043079 | Bicontact Hip System with U-Cap | Aesculap | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K955033 | Rim Flare Acetabular ComponentSummary page 1…Orthopedics currently markets a polyethylene shell liner (insert) in conjunction with its Inter-Op Acetabular System. The UHMWPE insert was originally cleared via 510(k) K955033 and is available in three styles, all of which mate with various shell designs in the system. The purpose of this submission is… | 1996 |
What descends from it? (327)
See all 3272 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?
- Its one ancestor has no recall.
- Of its descendants, K993259 (Sulzer Orthopedics, Inc., 2000) has gone furthest, with 326 descendants of its own.
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 DURASUL acetabular insert is a snap-in acetabular shell liner that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The insert is available in three styles and is intended to be used in conjunction with an Inter-Op acetabular shell to replace the acetabulum during total hip arthroplasty. Inter-Op acetabular components (shell/insert combination) may be implanted with or without bone cement. Diagnostic indications for use of this…
Read the full statement (106 words)
The DURASUL acetabular insert is a snap-in acetabular shell liner that is manufactured from ultra-high molecular weight polyethylene (UHMWPE). The insert is available in three styles and is intended to be used in conjunction with an Inter-Op acetabular shell to replace the acetabulum during total hip arthroplasty. Inter-Op acetabular components (shell/insert combination) may be implanted with or without bone cement.
Diagnostic indications for use of this device include:
patient conditions of noninflammatory degenerative joint disease (NIDJD); e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
those patients with 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/K983509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983509: Inter-OP Acetabular System - Durasul Acetabular Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983509
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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