510(k) · Cleared

Cleared

Optetrak Total Knee System Size 0/1 Delta (Line Extension)

K011976510(k) SpecialCleared Jul 16, 200121-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 Jul 16, 2001 as substantially equivalent to K932690 (Exactech, Inc., 1995) and 6 other predicates after a 21-day review. Its family tree reaches back 1 generation to 1994. 107 later devices descend from it.

Decided: Jul 16, 2001
Review: 21 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 7

Its longest line of descent runs back 1 generation to K936079 (1994). 7 ancestors in all. 107 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
This deviceK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
Descendant · cites it directly · 86 of its ownK030686 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

Showing 5 of 107 descendants. See all descendants

Descendants cleared per year

2002high 14 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 107 · See all

K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003 · cites it directly86descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K936079	Ecactech Porous Coated Finned Tibial Tray Compnent	Exactech, Inc.	1994	—
0 (this device)	K011976	Optetrak Total Knee System Size 0/1 Delta (Line Extension)	Exactech, Inc.	2001	—
+1	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	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0
2004	1	0
2007	1	0
2009	1	0
2010	2	0
2011	2	0
2012	4	0
2013	8	0
2014	9	0
2015	5	0
2016	11	0
2017	6	0
2018	4	0
2019	4	0
2020	5	0
2021	14	0
2022	5	0
2023	10	0
2024	1	0
2025	9	0
2026	2	0

FIG. 1 — Lineage of K011976, 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? (10)

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
*	K932690	Exactech Cruciate Retaining Cemented Total Knee SY Summary page 2 …: Orthopedic Legally Marketed Devices for Substantial Equivalence Comparison: Exactech Predicate Devices Model Manufacturer 510(k) Number Optetrak CR Femoral Exactech #K932690 Optetrak PS Femoral Exactech #K933494 Optetrak Porous CR Femoral Exactech #K935726 Optetrak PS Tibial Insert Exactech #K933610 Op…	Exactech, Inc.	1995	6
*	K933494	Exactech Posterior Stabilized Cemented Total Knee System Summary page 2 …for Substantial Equivalence Comparison: Exactech Predicate Devices Model Manufacturer 510(k) Number Optetrak CR Femoral Exactech #K932690 Optetrak PS Femoral Exactech #K933494 Optetrak Porous CR Femoral Exactech #K935726 Optetrak PS Tibial Insert Exactech #K933610 Optetrak CR Tibial Insert Exactech #K932…	Exactech, Inc.	1995	2
*	K935726	Exactech Porous Coated Cruciate Retained Femoral Component Summary page 2 …tech Predicate Devices Model Manufacturer 510(k) Number Optetrak CR Femoral Exactech #K932690 Optetrak PS Femoral Exactech #K933494 Optetrak Porous CR Femoral Exactech #K935726 Optetrak PS Tibial Insert Exactech #K933610 Optetrak CR Tibial Insert Exactech #K932776 Optetrak CC Tibial Insert Exactech #K9542…	Exactech, Inc.	1994	—
*	K933610	Exactech Cemented Total Knee System, Tibial Components Summary page 2 …10(k) Number Optetrak CR Femoral Exactech #K932690 Optetrak PS Femoral Exactech #K933494 Optetrak Porous CR Femoral Exactech #K935726 Optetrak PS Tibial Insert Exactech #K933610 Optetrak CR Tibial Insert Exactech #K932776 Optetrak CC Tibial Insert Exactech #K954208 Optetrak Finned Tibial Tray Exactech #K93…	Exactech, Inc.	1995	7
*	K932776	Cruciate Retaining Cemented Tibial Components Summary page 2 …932690 Optetrak PS Femoral Exactech #K933494 Optetrak Porous CR Femoral Exactech #K935726 Optetrak PS Tibial Insert Exactech #K933610 Optetrak CR Tibial Insert Exactech #K932776 Optetrak CC Tibial Insert Exactech #K954208 Optetrak Finned Tibial Tray Exactech #K932776 Optetrak Finned Porous Tibial Tray Exac…	Exactech, Inc.	1994	2
*	K954208	Optetrak Constrained Condylar Knee for Cemented Use Only Summary page 2 …Optetrak Porous CR Femoral Exactech #K935726 Optetrak PS Tibial Insert Exactech #K933610 Optetrak CR Tibial Insert Exactech #K932776 Optetrak CC Tibial Insert Exactech #K954208 Optetrak Finned Tibial Tray Exactech #K932776 Optetrak Finned Porous Tibial Tray Exactech #K936079 Optetrak Trapezoidal Tibial Tr…	Exactech, Inc.	1996	1
*	K936079	Ecactech Porous Coated Finned Tibial Tray Compnent Summary page 2 …CR Tibial Insert Exactech #K932776 Optetrak CC Tibial Insert Exactech #K954208 Optetrak Finned Tibial Tray Exactech #K932776 Optetrak Finned Porous Tibial Tray Exactech #K936079 Optetrak Trapezoidal Tibial Tray Exactech #K933610 Optetrak Tibial Augments Exactech #K9336 10 Predicate Devices from other Manu…	Exactech, Inc.	1994	—
*	—	Nexgen Named without a submission number			—
*	—	Maxim Named without a submission number			—
*	—	PFC Named without a submission number			—

Also cleared against K932690: 5 other devices →

What descends from it? (107)

See all 107

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

Number	Device	Applicant	Decided	Descendants
K030686	Optetrak Total Knee System - Molded Metal-Back Tibial Component	Exactech, Inc.	2003	86
K100900	Motivation Knee System	Encore Medical L.P.	2010	72
K032606	Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing…	Exactech, Inc.	2003	18
K033883	Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral…	Exactech, Inc.	2004	17
K023186	Optetrak Total Knee System Offset Tibial Tray	Exactech, Inc.	2002	1
K071738	Exactech Optetrak Proximal Tibial Spacer	Exactech, Inc.	2007	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?

5 of the 7 ancestors have a recall of any class.
Of its descendants, K030686 (Exactech, Inc., 2003) has gone furthest, with 86 descendants of its own.
5 other devices also cite its predicate K932690.

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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K011976 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011976: Optetrak Total Knee System Size 0/1 Delta (Line Extension).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011976

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026