510(k) · Cleared
ClearedInter-OP HA Porous Acetabular System (HA/Csti)
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 Sep 19, 1997 after an 85-day review. The FDA summary names its predicate without a number. 312 later devices descend from it.
- Decided
- Sep 19, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 0
312 later devices descend from it, 3 citing it directly.
- This deviceK972393 Inter-OP HA Porous Acetabular System (HA/Csti)Sulzer Orthopedics, Inc. · 1997
- Descendant · cites it directly · 309 of its ownK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 296 of its ownK030733 Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 267 of its ownK040191 Bicontact Hip Stem and Femoral HeadAesculap · 2004
- Descendant · cites it directly · 213 of its ownK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- Descendant · 2 generations on · 207 of its ownK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
Showing 5 of 312 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 312 · See all- K980711Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc. · 1998 · cites it directly309descendants
- K030733Mayo Conservative Hip Prosthesis, Model 8026 SeriesZimmer, Inc. · 2003 · 2 generations on296descendants
- K040191Bicontact Hip Stem and Femoral HeadAesculap · 2004 · 3 generations on267descendants
- K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000 · cites it directly213descendants
- K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003 · 2 generations on207descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972393 | Inter-OP HA Porous Acetabular System (HA/Csti) | Sulzer Orthopedics, Inc. | 1997 | — |
| +1 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| +2 | K030733 | Mayo Conservative Hip Prosthesis, Model 8026 Series | Zimmer, Inc. | 2003 | 2 |
| +3 | K040191 | Bicontact Hip Stem and Femoral Head | Aesculap | 2004 | — |
| +1 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| +2 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 16 | 0 |
| 2012 | 26 | 0 |
| 2013 | 23 | 0 |
| 2014 | 8 | 0 |
| 2015 | 9 | 0 |
| 2016 | 11 | 0 |
| 2017 | 17 | 0 |
| 2018 | 17 | 0 |
| 2019 | 15 | 0 |
| 2020 | 17 | 0 |
| 2021 | 19 | 0 |
| 2022 | 18 | 0 |
| 2023 | 20 | 0 |
| 2024 | 16 | 0 |
| 2025 | 23 | 0 |
| 2026 | 20 | 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? (3)
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 |
|---|---|---|---|
| * | — | Inter-Op Porous Acetabular System Named without a submission number | |
| * | — | APR HA Porous Hip System Named without a submission number | |
| * | — | Natural-Hip HA Named without a submission number |
What descends from it? (312)
See all 3123 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?
- Of its descendants, K980711 (Zimmer, Inc., 1998) has gone furthest, with 309 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?
Components of the Inter-Op HA Porous Acetabular System are intended to replace the acetabulum during total hip arthroplasty. The four metallic shell styles are porous coated and used in conjunction with a snap-in polyethylene liner. The acetabular components of this system are intended to achieve biological fixation to bone without the use of bone cement. While three of the shell styles are hemispherical, the Protrusio HA Porous Shell is designed to…
Read the full statement (166 words)
Components of the Inter-Op HA Porous Acetabular System are intended to replace the acetabulum during total hip arthroplasty. The four metallic shell styles are porous coated and used in conjunction with a snap-in polyethylene liner. The acetabular components of this system are intended to achieve biological fixation to bone without the use of bone cement.
While three of the shell styles are hemispherical, the Protrusio HA Porous Shell is designed to compensate for protrusio defects where there has been thinning of the medial and superior walls of the acetabulum. The inner diameter is hemispherical while the outer shell has a 10mm build up, thus maintaining the anatomical hip center and avoiding the medialization of the femoral component.
Diagnostic indications for use of components of the Inter-Op HA Porous Acetabular System include:
revision of a previously implanted acetabular prosthesis;
patient conditions of noninflammatory degenerative joint disease; e.g., avascular necrosis, osteoarthritis, or arthritis secondary to a variety of diseases and anomalies;
and,
inflammatory joint disease; e.g., rheumatoid arthritis.
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/K972393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972393: Inter-OP HA Porous Acetabular System (HA/Csti).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972393
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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