510(k) · Cleared
ClearedA200 Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovis Surgical Technologies, LLC · OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Cleared on Feb 14, 2013 as substantially equivalent to K060515 (DePuy Orthopaedics, Inc., 2006) and 6 other predicates after a 406-day review. Its family tree reaches back 8 generations to 1981. 2 later devices descend from it.
- Decided
- Feb 14, 2013
- Review
- 406 days
- Class
- Class II
- Product code
- OIY
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K810258 (1981). 53 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 7 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 6 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 5 generations backK042051 Arcomxl Polyethylene LinersBiomet, Inc. · 2005 · Recalled
- 4 generations backK051411 Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc. · 2005 · Recalled
- 3 generations backK061312 36MM Biolox Delta Ceramic HeadsBiomet, Inc. · 2006
- 2 generations backK073102 Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp · 2007
- 1 generation backK100048 E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp · 2010
- This deviceK120038 A200 Knee SystemRenovis Surgical Technologies, LLC · 2013
- Descendant · cites it directly · 1 of its ownK190122 Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies · 2019
- Descendant · cites it directly · 0 of its ownK243295 Initia Knee SystemKyocera Medical Technologies, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −7 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −6 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −5 | K042051 | Arcomxl Polyethylene Liners | Biomet, Inc. | 2005 | 1 |
| −4 | K051411 | Arcomxl Polyethylene Liners and Biolox Delta Heads | Biomet, Inc. | 2005 | 1 |
| −3 | K061312 | 36MM Biolox Delta Ceramic Heads | Biomet, Inc. | 2006 | — |
| −2 | K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular Liners | Biomet Manufacturing Corp | 2007 | — |
| −1 | K100048 | E1 Antioxidant Infused Technology | Biomet Manufacturing Corp | 2010 | — |
| 0 (this device) | K120038 | A200 Knee System | Renovis Surgical Technologies, LLC | 2013 | — |
| +1 | K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee System | Renovis Surgical Technologies | 2019 | — |
| +1 | K243295 | Initia Knee System | Kyocera Medical Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 OIY? 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 OIY device
- #1 K252887 DePuy ATTUNE™ Knee Systemscore 12.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K060515 | Depuy PFC Sigma Knee ProsthesisSummary page 2…f which has been determined by FDA to be Substantially equivalent to a legally marketed predicate device: DePuy Orthopaedics, Inc., DePuy Sigma Knee Femoral Adapter, K0605 15; Encore Medical. L.P., Highly Cross-Linked Vitamin E UHIMWPE Tibial Insert, K103223; Biomet Manufacturing Corp., E I'm Ti… | 2006 |
| * | K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsSummary page 2…redicate device: DePuy Orthopaedics, Inc., DePuy Sigma Knee Femoral Adapter, K0605 15; Encore Medical. L.P., Highly Cross-Linked Vitamin E UHIMWPE Tibial Insert, K103223; Biomet Manufacturing Corp., E I'm Tibial Bearings, K 100048; Encore Orthopedics, Inc., Foundation Knee System, K<923277;… | 2010 |
| * | K100048 | E1 Antioxidant Infused TechnologySummary page 2…Femoral Adapter, K0605 15; Encore Medical. L.P., Highly Cross-Linked Vitamin E UHIMWPE Tibial Insert, K103223; Biomet Manufacturing Corp., E I'm Tibial Bearings, K 100048; Encore Orthopedics, Inc., Foundation Knee System, K<923277; Zimmer, Inc., MG 11 Porous Total Knee System, K892800; U… | 2010 |
| * | K923277 | Foundation Knee SystemSummary page 3…ickness and diameter of the patellar components. Constraint, contact area, and contact stress testing demonstrated the A200 Knee System to be substantially equivalent to K923277, K892800 K932837, and K935080. The A200 Knee System and the predicate devices K103223 and K100048 include tibial inserts manufact… | 1993 |
| * | K892800 | MG II Porous Total Knee SystemSummary page 2…t Manufacturing Corp., E I'm Tibial Bearings, K 100048; Encore Orthopedics, Inc., Foundation Knee System, K<923277; Zimmer, Inc., MG 11 Porous Total Knee System, K892800; U.S. Medical Products, Inc., Consensus Knee System - Primary Knee, K932837; and Hospital for Special Surgery, Insall-Bur… | 1989 |
| * | K932837 | Consensus Knee System - Primary KneeSummary page 2…Inc., Foundation Knee System, K<923277; Zimmer, Inc., MG 11 Porous Total Knee System, K892800; U.S. Medical Products, Inc., Consensus Knee System - Primary Knee, K932837; and Hospital for Special Surgery, Insall-Burstein 11, K935080.… | 1994 |
| * | K935080 | Insall-Burstein IISummary page 2…ous Total Knee System, K892800; U.S. Medical Products, Inc., Consensus Knee System - Primary Knee, K932837; and Hospital for Special Surgery, Insall-Burstein 11, K935080. Page 101 of 107 5… | 1995 |
What descends from it? (2)
2 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?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 16 of the 53 ancestors have a recall of any class.
- Of its descendants, K190122 (Renovis Surgical Technologies, 2019) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K060515.
How does its category compare?
All OIY devicesOIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OIY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OIY
132in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OIY
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OIY
35in 2025
MAUDE reports naming product code OIY, 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 | 4 | 132 | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 1 | 84 |
| 2015 | 0 | — | 1 | 282 |
| 2016 | 0 | — | 0 | 130 |
| 2017 | 0 | — | 0 | 91 |
| 2018 | 0 | — | 0 | 68 |
| 2019 | 0 | — | 0 | 78 |
| 2020 | 1 | — | 0 | 121 |
| 2021 | 0 | — | 0 | 379 |
| 2022 | 0 | — | 0 | 42 |
| 2023 | 0 | — | 0 | 40 |
| 2024 | 1 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The A200 Knee System is intended for use in total knee arthroplasty for the following
indications:
1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic
arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint
replacement procedure.
This device is intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120038 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120038: A200 Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120038
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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