510(k) · Cleared
ClearedRenovis Tesera Trabecular Technology (T3) Acetabular Shell System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovis Surgical Technologies, LLC · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Apr 11, 2014 as substantially equivalent to K112897 (Renovis Surgical Technologies, LLC, 2012) and 1 other predicate after a 260-day review. Its family tree reaches back 8 generations to 1994. 6 later devices descend from it.
- Decided
- Apr 11, 2014
- Review
- 260 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K931641 (1994). 93 ancestors in all, the oldest K810258 (1981). 6 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 7 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 6 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 5 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 4 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 3 generations backK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- 2 generations backK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
- 1 generation backK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
- This deviceK132312 Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC · 2014
- Descendant · cites it directly · 4 of its ownK141676 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 ownK242045 Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc. · 2025
- 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc. · 2014 · cites it directly4descendants
- K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. · 2020 · cites it directly1descendant
- K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc. · 2025 · cites it directly0descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −7 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −6 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −5 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −4 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −3 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| −2 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
| −1 | K102975 | Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole | Exactech, Inc. | 2010 | — |
| 0 (this device) | K132312 | Renovis Tesera Trabecular Technology (T3) Acetabular Shell System | Renovis Surgical Technologies, LLC | 2014 | — |
| +1 | 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 | K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | 2025 | — |
| +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 | — |
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 | 3 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (2)
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 Prosthesis | 2012 |
| * | K102975 | Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleSummary page 1…e: LPH Classification panel: Orthopedic C) Predicates: Kl 12897 Renovis A400 Surgical Hip Replacement System (acetabular shells) K102975 Exactech Novation Crown Cup with InteGrip Acetabular Shell ORENOVIS… | 2010 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141676 | Renovis Surgical Porous Acetabular Cup System | 2014 | 4 |
| K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | 2020 | 1 |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | 2025 | 0 |
| K203472 | KMTI Hip Replacement System | 2021 | 0 |
| K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell… | 2020 | 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 4 companies; a new generation was cleared every 1.6 years on median.
- 24 of the 93 ancestors have a recall of any class.
- Of its descendants, K141676 (Renovis Surgical Technologies, Inc., 2014) has gone furthest, with 4 descendants 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 Tesera Trabecular Technologies (T3) Acetabular Shell System components are to be used with components of the Renovis A400 Surgical Hip Replacement System, and are indicated for patients suffering from: 1. Non-inflammatory degenerative joint disease including osteoartbritis and avascular necrosis; 2. Rheumatoid arthritis; 3. Correction of functional deformity; 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the…
Read the full statement (95 words)
The Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System components are to be used with components of the Renovis A400 Surgical Hip Replacement System, and are indicated for patients suffering from: 1. Non-inflammatory degenerative joint disease including osteoartbritis 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.
The Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System is intended for cementless applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132312: Renovis Tesera Trabecular Technology (T3) Acetabular Shell System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132312
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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