510(k) · Cleared
ClearedRenovis Surgical Porous Acetabular Cup System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovis Surgical Technologies, Inc. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 4, 2014 as substantially equivalent to K112897 (Renovis Surgical Technologies, LLC, 2012) and 2 other predicates after a 134-day review. Its family tree reaches back 9 generations to 1994. 4 later devices descend from it.
- Decided
- Nov 4, 2014
- Review
- 134 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K931641 (1994). 95 ancestors in all, the oldest K810258 (1981). 4 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 5 generations between
- 3 generations backK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
- 2 generations backK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
- 1 generation backK132312 Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC · 2014
- This deviceK141676 Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK200328 Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous…Kyocera Medical Technologies, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK203472 KMTI Hip Replacement SystemKyocera Medical Technologies, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK201660 KMTI Hip Replacement System, Tesera Trabecular Technologies (T3)…Kyocera Medical Technologies, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK171543 Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies · 2017
Show all 9 generations
- Root · 9 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 8 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 7 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 6 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 5 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 4 generations backK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- 3 generations backK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
- 2 generations backK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
- 1 generation backK132312 Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC · 2014
- This deviceK141676 Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc. · 2014
Most influential descendants
Showing 4 of 4 · See all- K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. · 2020 · cites it directly1descendant
- K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc. · 2021 · cites it directly0descendants
- K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc. · 2020 · cites it directly0descendants
- K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −8 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −7 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −6 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −5 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −4 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| −3 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
| −2 | K102975 | Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole | Exactech, Inc. | 2010 | — |
| −1 | K132312 | Renovis Tesera Trabecular Technology (T3) Acetabular Shell System | Renovis Surgical Technologies, LLC | 2014 | — |
| 0 (this device) | K141676 | Renovis Surgical Porous Acetabular Cup System | Renovis Surgical Technologies, Inc. | 2014 | — |
| +1 | K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular… | Kyocera Medical Technologies, Inc. | 2020 | — |
| +1 | K203472 | KMTI Hip Replacement System | Kyocera Medical Technologies, Inc. | 2021 | — |
| +1 | K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular… | Kyocera Medical Technologies, Inc. | 2020 | — |
| +1 | K171543 | Renovis Surgical Hip Replacement System | Renovis Surgical Technologies | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 14 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2005 | 7 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K112897 | Renovis Surgical Hip Joint Replacement ProsthesisSummary page 4…semi-constrained porous-coated uncemented prosthesis Product code: LPH Classification panel: Orthopedic C) Predicates: K112897 Renovis A400 Surgical Hip Joint Replacement System (acetabular shells) K132312 Renovis Tesera Trabecular… | 2012 |
| * | K132312 | Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemSummary page 4…de: LPH Classification panel: Orthopedic C) Predicates: K112897 Renovis A400 Surgical Hip Joint Replacement System (acetabular shells) K132312 Renovis Tesera Trabecular Technology (T3) Acetabular Shell System K974093 Encore Orthopedics Foundation P… | 2014 |
| * | K974093 | Foundation Porous Coated Hemispherical ShellSummary page 4…Renovis A400 Surgical Hip Joint Replacement System (acetabular shells) K132312 Renovis Tesera Trabecular Technology (T3) Acetabular Shell System K974093 Encore Orthopedics Foundation Porous Coated Hemispherical Acetabular Cup Renovis Surgical Po… | 1998 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | 2020 | 1 |
| K203472 | KMTI Hip Replacement System | 2021 | 0 |
| K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell… | 2020 | 0 |
| K171543 | Renovis Surgical Hip Replacement System | 2017 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 24 of the 95 ancestors have a recall of any class.
- Of its descendants, K200328 (Kyocera Medical Technologies, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K112897.
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. 2014, 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?
The Renovis Surgical Hip Replacement System is indicated for patients suffering from:
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
5. Revision procedures where other treatment or devices have failed.
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/K141676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141676: Renovis Surgical Porous Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141676
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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