510(k) · Cleared
ClearedKMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kyocera Medical Technologies, Inc. · OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Cleared on Jul 16, 2020 as substantially equivalent to K200328 (Kyocera Medical Technologies, Inc., 2020) and 2 other predicates after a 28-day review. Its family tree reaches back 11 generations to 1994.
- Decided
- Jul 16, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- OQG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K931641 (1994). 97 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 11 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 7 generations between
- 3 generations backK132312 Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC · 2014
- 2 generations backK141676 Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc. · 2014
- 1 generation backK200328 Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous…Kyocera Medical Technologies, Inc. · 2020
- This deviceK201660 KMTI Hip Replacement System, Tesera Trabecular Technologies (T3)…Kyocera Medical Technologies, Inc. · 2020
Show all 11 generations
- Root · 11 generations backK931641 Porocoat Porous CoatingDepuy, Inc. · 1994
- 10 generations backK003800 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 9 generations backK012364 Aml Hip ProsthesisDePuy Orthopaedics, Inc. · 2001
- 8 generations backK030236 Acumatch P-Series Porous Press-Fit Femoral ComponentExactech, Inc. · 2003
- 7 generations backK041906 Exactech 12/14 Total Hip SystemExactech, Inc. · 2004 · Recalled
- 6 generations backK051556 Acumatch a-Series Connexion GXL Enhanced Crosslinked PolythyleneExactech, Inc. · 2005 · Recalled
- 5 generations backK070479 Exactech Novation Crown Cup and LinersExactech, Inc. · 2007 · Recalled
- 4 generations backK102975 Novation Crown Cup with Integrip Acetabular Shell, Cluster-HoleExactech, Inc. · 2010
- 3 generations backK132312 Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC · 2014
- 2 generations backK141676 Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc. · 2014
- 1 generation backK200328 Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous…Kyocera Medical Technologies, Inc. · 2020
- This deviceK201660 KMTI Hip Replacement System, Tesera Trabecular Technologies (T3)…Kyocera Medical Technologies, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931641 | Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −10 | K003800 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −9 | K012364 | Aml Hip Prosthesis | DePuy Orthopaedics, Inc. | 2001 | — |
| −8 | K030236 | Acumatch P-Series Porous Press-Fit Femoral Component | Exactech, Inc. | 2003 | — |
| −7 | K041906 | Exactech 12/14 Total Hip System | Exactech, Inc. | 2004 | 1 |
| −6 | K051556 | Acumatch a-Series Connexion GXL Enhanced Crosslinked Polythylene | Exactech, Inc. | 2005 | 12 |
| −5 | K070479 | Exactech Novation Crown Cup and Liners | Exactech, Inc. | 2007 | 16 |
| −4 | K102975 | Novation Crown Cup with Integrip Acetabular Shell, Cluster-Hole | Exactech, Inc. | 2010 | — |
| −3 | K132312 | Renovis Tesera Trabecular Technology (T3) Acetabular Shell System | Renovis Surgical Technologies, LLC | 2014 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | 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 |
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 OQG? 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 OQG device
- #1 K200328 Tesera Trabecular Technologies (T3) Acetabular…score 4.7 · 10 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 |
|---|---|---|---|
| * | K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemSummary page 5…Class II Regulation: 21 CFR 888.3358 Product Code: OQG, LPH, LZO, OQI Classification panel: Orthopedic C) Predicates: Primary: K200328 Kyocera Medical Technologies, Inc. ("KMTI") Hip Replacement System Secondary: K1… | 2020 |
| * | K132312 | Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemSummary page 5…dic C) Predicates: Primary: K200328 Kyocera Medical Technologies, Inc. ("KMTI") Hip Replacement System Secondary: K132312 Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System Secondary: K… | 2014 |
| * | K141676 | Renovis Surgical Porous Acetabular Cup SystemSummary page 5…tem Secondary: K132312 Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System Secondary: K141676 Renovis Porous Acetabular Cup System D) Date Prepared: June 16, 2020 KMTI Hip Replacement System… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 24 of the 97 ancestors have a recall of any class.
How does its category compare?
All OQG devicesOQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OQG
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OQG
99in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OQG
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQG
16in 2025
MAUDE reports naming product code OQG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 5 | 144 | 0 | 0 |
| 2013 | 3 | 280 | 1 | 5 |
| 2014 | 3 | 99 | 0 | 31 |
| 2015 | 1 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 3 | 99 | 0 | 27 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 104 |
| 2020 | 2 | — | 0 | 178 |
| 2021 | 2 | — | 0 | 88 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KMTI 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…
Read the full statement (306 words)
The KMTI 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.
Qualifiers:
The KMTI A400 Hip System is intended for cementless applications unless used with the KMTI Cemented Hip Stem.
The KMTI Porous Coated Acetabular Shell System is intended for cementless applications. In addition, the KMTI Porous Coated Acetabular Shell and Universal liners can be used with:
• The Kyocera Corporation (“KYOCERA”) Initia Total Hip System femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
The Cemented Hip Stem is intended for cemented applications.
The KMTI Tesera Trabecular Technology (T3) Acetabular Shell System is intended for cementless applications. In addition, the KMTI T3 Acetabular Shell and Universal Liners can be used with:
• The KYOCERA Initia femoral stem mated with KYOCERA CoCr (28–40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KMTI femoral stem mated with KYOCERA CoCr (28–40mm) or BIOCERAM AZUL (28-40mm) femoral head.
The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems.
In addition:
• The KYOCERA Initia Total Hip System 28mm CoCr and 28mm BIOCERAM AZUL femoral head and Initia femoral stems can be used with the KMTI 28mm ID Bipolar Head.
• The KYOCERA Initia Total Hip System femoral stem can be used with the KMTI 22mm CoCr femoral head and KMTI 22mm ID Bipolar Head.
The Bipolar Head is for uncemented use only.
Bipolar outer heads are not for use with acetabular shells and liners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201660 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201660: KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201660
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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