510(k) · Cleared
ClearedTriathlon AS-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conformis, Inc. · OOG Knee Arthroplasty Implantation System
Cleared on Apr 19, 2021 as substantially equivalent to K180906 (Conformis, Inc., 2018) and 1 other predicate after a 150-day review. Its family tree reaches back 18 generations to 1981.
- Decided
- Apr 19, 2021
- Review
- 150 days
- Class
- Class II
- Product code
- OOG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K810258 (1981). 177 ancestors in all. No later device cites it as a predicate yet.
- Root · 18 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 14 generations between
- 3 generations backK180906 Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2018 · Recalled
- 2 generations backK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
- 1 generation backK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
- This deviceK203421 Triathlon AS-1Conformis, Inc. · 2021
Show all 18 generations
- Root · 18 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
- 17 generations backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
- 16 generations backK032396 Ringloc 36MM Line and Modular Femoral HeadsBiomet, Inc. · 2003 · Recalled
- 15 generations backK050327 E-Poly (Vitamin E) Acetabular LinersBiomet, Inc. · 2005
- 14 generations backK070364 100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc. · 2007
- 13 generations backK080528 E-Poly Tibial BearingsBiomet Orthopedics, Inc. · 2008
- 12 generations backK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
- 11 generations backK103223 Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P. · 2010
- 10 generations backK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
- 9 generations backK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
- 8 generations backK140423 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2014 · Recalled
- 7 generations backK142161 Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal…Conformis, Inc. · 2014 · Recalled
- 6 generations backK152704 iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate…Conformis, Inc. · 2015
- 5 generations backK160025 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal…Conformis, Inc. · 2016 · Recalled
- 4 generations backK161366 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System…Conformis, Inc. · 2016
- 3 generations backK180906 Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2018 · Recalled
- 2 generations backK190562 iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc. · 2019
- 1 generation backK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
- This deviceK203421 Triathlon AS-1Conformis, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K810258 | Proximal Fermoral Hip Replacement | Biomet, Inc. | 1981 | — |
| −17 | K974558 | Salvage/Onocology Hip and Total Femur System | Biomet, Inc. | 1998 | — |
| −16 | K032396 | Ringloc 36MM Line and Modular Femoral Heads | Biomet, Inc. | 2003 | 3 |
| −15 | K050327 | E-Poly (Vitamin E) Acetabular Liners | Biomet, Inc. | 2005 | — |
| −14 | K070364 | 100KGY E-Poly Maxrom Acetabular Liners | Biomet, Inc. | 2007 | — |
| −13 | K080528 | E-Poly Tibial Bearings | Biomet Orthopedics, Inc. | 2008 | — |
| −12 | K091956 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 | Encore Medical L.P. | 2010 | 4 |
| −11 | K103223 | Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts | Encore Medical L.P. | 2010 | — |
| −10 | K122870 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2013 | — |
| −9 | K131019 | Itotal Cruciate Retaining (C) Knee Replacement System | Conformis, Inc. | 2013 | — |
| −8 | K140423 | Itotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2014 | 1 |
| −7 | K142161 | Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior… | Conformis, Inc. | 2014 | 6 |
| −6 | K152704 | iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining… | Conformis, Inc. | 2015 | — |
| −5 | K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate… | Conformis, Inc. | 2016 | 1 |
| −4 | K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) | Conformis, Inc. | 2016 | — |
| −3 | K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System | Conformis, Inc. | 2018 | 4 |
| −2 | K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | Conformis, Inc. | 2019 | — |
| −1 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Conformis, Inc. | 2020 | — |
| 0 (this device) | K203421 | Triathlon AS-1 | Conformis, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 5 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 13 | 0 |
| 1996 | 9 | 0 |
| 1997 | 9 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 8 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 7 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 9 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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 OOG? 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 OOG device
- #1 K230850 United Orthopedic Knee Patient Specific…score 8.6 · 8 generations · no Class I recall
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 |
|---|---|---|---|
| * | K180906 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemSummary page 4…Code Regulation 21 CFR 888.3560 Product Code Device Name: Knee Arthroplasty Implantation System Legally Marketed Predicate Device: 510(k): K180906 Primary Predicate: Device: iTotal® Cruciate Retaining (CR) Knee Replacement System… | 2018 |
| * | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement SystemSummary page 5…Page 5 === K203421 - Page 2 of 4 Legally Marketed Predicate Device: 510(k): K201023 Secondary Predicate: Device: iTotal® Identity Posterior Stabilized Knee Replacement… | 2020 |
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 40 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 83 of the 177 ancestors have a recall of any class.
- 2 other devices also cite its predicate K180906.
How does its category compare?
All OOG devicesOOG Knee Arthroplasty Implantation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OOG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OOG
Too few OOG 510(k)s in any year since 2007 to give a median.
Recalls per year · OOG
3in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OOG
34in 2025
MAUDE reports naming product code OOG, 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 | 6 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 3 | 30 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 1 | — | 0 | 23 |
| 2024 | 0 | — | 0 | 72 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Triathlon AS-I patient specific cutting guides are disposable, single-use surgical instruments intended to assist orthopedic surgeons in the positioning of femoral and tibial total knee arthroplasty components intraoperatively, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. They are intended for use with the Cruciate Retaining (CR), Condylar Stabilizing (CS), Posterior Stabilized (PS) and Tritanium@ components of the Triathlon@ Total Knee System and the Total Stabilizer (TS) and Posterior Stabilized Rotation (PSR) Triathlon@ tibial inserts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203421: Triathlon AS-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203421
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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