510(k) · Cleared

Cleared

Optetrak Total Knee System - Molded Metal-Back Tibial Component

K030686510(k) SpecialCleared Apr 2, 200328-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Exactech, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Apr 2, 2003 as substantially equivalent to K932776 (Exactech, Inc., 1994) and 4 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1994. 86 later devices descend from it.

Decided: Apr 2, 2003
Review: 28 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K936079 (1994). 10 ancestors in all, the oldest K810520 (1981). 86 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
1 generation backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
This deviceK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
Descendant · cites it directly · 72 of its ownK100900 Motivation Knee SystemEncore Medical L.P. · 2010 · Recalled
Descendant · 2 generations on · 35 of its ownK113756 Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE…Encore Medical L.P. · 2012 · Recalled
Descendant · 3 generations on · 33 of its ownK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
Descendant · 4 generations on · 30 of its ownK131467 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
Descendant · 4 generations on · 30 of its ownK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

2009high 14 (2021) · low 0 (2011)2026

Most influential descendants

Showing 5 of 86 · See all

K100900Motivation Knee SystemEncore Medical L.P. · 2010 · cites it directly72descendants
K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P. · 2012 · 2 generations on35descendants
K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013 · 3 generations on33descendants
K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013 · 4 generations on30descendants
K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013 · 4 generations on30descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K936079	Ecactech Porous Coated Finned Tibial Tray Compnent	Exactech, Inc.	1994	—
−1	K011976	Optetrak Total Knee System Size 0/1 Delta (Line Extension)	Exactech, Inc.	2001	—
0 (this device)	K030686	Optetrak Total Knee System - Molded Metal-Back Tibial Component	Exactech, Inc.	2003	—
+1	K100900	Motivation Knee System	Encore Medical L.P.	2010	4
+2	K113756	Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg…	Encore Medical L.P.	2012	1
+3	K122870	Itotal Cruciate Retaining (CR) Knee Replacement System	Conformis, Inc.	2013	—
+4	K131467	Itotal Cruciate Retaining (CR) Knee Replacement System	Conformis, Inc.	2013	—
+4	K131019	Itotal Cruciate Retaining (C) Knee Replacement System	Conformis, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1981	1	0
1984	1	0
1994	2	0
1995	3	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2012	3	0
2013	5	0
2014	8	0
2015	3	0
2016	9	0
2017	4	0
2018	3	0
2019	4	0
2020	5	0
2021	14	0
2022	5	0
2023	9	0
2024	1	0
2025	9	0
2026	2	0

FIG. 1 — Lineage of K030686, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JWH? 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 JWH device

#1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K932776	Cruciate Retaining Cemented Tibial Components Summary page 1 …The articulating surfaces of the Exactech Optetrak Tibial Tray Insert components (K933610 and KO1 1976) 2) The tibial stem of the Cemented Finned Tibial Tray components (K932776 and KO1 1976)' Section 4…	Exactech, Inc.	1994	2
*	K011976	Optetrak Total Knee System Size 0/1 Delta (Line Extension)	Exactech, Inc.	2001	—
*	K933610	Exactech Cemented Total Knee System, Tibial Components Summary page 1 …and design, the proposed Molded Metal-back Tibial components are a combination of: 1) The articulating surfaces of the Exactech Optetrak Tibial Tray Insert components (K933610 and KO1 1976) 2) The tibial stem of the Cemented Finned Tibial Tray components (K932776 and KO1 1976)'…	Exactech, Inc.	1995	7
*	K833921	Agc Total Knee Prosthesis Summary page 1 …76 Extension - Cemented Finned Tibial Tray Components and Posterior Stabilized Tibial Inserts AGC Total Knee Prosthesis - Posterior-Stabilized Biomet K833921 Tibial Components InsalVBurstein Constrained Total Condylar Knee Zimmer K8 10520 In materials and design,…	Biomet, Inc.	1984	2
*	K810520	Insall/Burstein Constrained Total Condyl Summary page 1 …l Knee Prosthesis - Posterior-Stabilized Biomet K833921 Tibial Components InsalVBurstein Constrained Total Condylar Knee Zimmer K8 10520 In materials and design, the proposed Molded Metal-back Tibial components are a combination of: 1) The articulating surfaces of…	Zimmer, Inc.	1981	—

Also cleared against K932776: 5 other devices →

What descends from it? (86)

See all 86

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K100900	Motivation Knee System	Encore Medical L.P.	2010	72
K090411	Freedom Metal Backed Tibial Component	Maxx Orthopedics, Inc.	2009	15

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 9 years and passes through 1 company; a new generation was cleared every 6.9 years on median.
6 of the 10 ancestors have a recall of any class.
Of its descendants, K100900 (Encore Medical L.P., 2010) has gone furthest, with 72 descendants of its own.
5 other devices also cite its predicate K932776.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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	18	74	14	1,305
2008	17	81	10	1,483
2009	11	168	109	1,870
2010	19	85	32	3,286
2011	25	87	27	5,133
2012	33	85	85	5,203
2013	31	128	31	6,135
2014	33	98	13	6,722
2015	27	87	11	6,881
2016	18	88	17	7,586
2017	25	118	61	12,263
2018	25	90	14	14,071
2019	28	133	5	14,987
2020	22	59	2	12,592
2021	24	61	8	9,408
2022	17	56	12	8,364
2023	20	57	67	8,947
2024	19	89	7	10,828
2025	20	55	2	9,306
2026	12	63	4	—

What is it indicated for?

The OPTETRAK@Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030686 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030686: Optetrak Total Knee System - Molded Metal-Back Tibial Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030686

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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