510(k) · Cleared

Cleared

Optetrak Total Knee System, Straight Stem Extensions - Additional Sizes

K012251510(k) SpecialCleared Jul 31, 200113-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 31, 2001 as substantially equivalent to K933610 (Exactech, Inc., 1995) and 1 other predicate after a 13-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.

Decided: Jul 31, 2001
Review: 13 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K933610 (1995). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK933610 Exactech Cemented Total Knee System, Tibial ComponentsExactech, Inc. · 1995 · Recalled
This deviceK012251 Optetrak Total Knee System, Straight Stem Extensions - Additional…Exactech, Inc. · 2001
Descendant · cites it directly · 3 of its ownK150890 Exactech Optetrak Logic CCExactech, Inc. · 2015 · Recalled
Descendant · 2 generations on · 2 of its ownK152170 Exactech Optetrak Logic Enhanced AssemblyExactech, Inc. · 2015 · Recalled
Descendant · 3 generations on · 1 of its ownK171045 Exactech® Truliant™ Line ExtensionsExactech, Inc. · 2017 · Recalled
Descendant · 2 generations on · 0 of its ownK223252 TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc. · 2023 · Recalled

Most influential descendants

Showing 4 of 4 · See all

K150890Exactech Optetrak Logic CCExactech, Inc. · 2015 · cites it directly3descendants
K152170Exactech Optetrak Logic Enhanced AssemblyExactech, Inc. · 2015 · 2 generations on2descendants
K171045Exactech® Truliant™ Line ExtensionsExactech, Inc. · 2017 · 3 generations on1descendant
K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc. · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933610	Exactech Cemented Total Knee System, Tibial Components	Exactech, Inc.	1995	7
0 (this device)	K012251	Optetrak Total Knee System, Straight Stem Extensions - Additional Sizes	Exactech, Inc.	2001	—
+1	K150890	Exactech Optetrak Logic CC	Exactech, Inc.	2015	4
+2	K152170	Exactech Optetrak Logic Enhanced Assembly	Exactech, Inc.	2015	3
+3	K171045	Exactech® Truliant™ Line Extensions	Exactech, Inc.	2017	2
+2	K223252	TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas	Exactech, Inc.	2023	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	2	0
2017	1	0
2023	1	0

FIG. 1 — Lineage of K012251, 1995–2023Source: 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

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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	Applicant	Decided	Recalls
*	K933610	Exactech Cemented Total Knee System, Tibial Components Summary page 2 …60 I Classification Panel: Orthopedic Legally Marketed Devices for Substantial Equivalence Comparison: Model Manufacturer 510(k) Number Optetrak Total Knee Exactech #K933610 Optetrak Total Knee Exactech #K954208 Nexgen Zimmer e Maxim Biomet =0 —eeemememeee- Durcon Total Stabilizer Howmedica ==mcmmmmmme…	Exactech, Inc.	1995	7
*	K954208	Optetrak Constrained Condylar Knee for Cemented Use Only Summary page 2 …c Legally Marketed Devices for Substantial Equivalence Comparison: Model Manufacturer 510(k) Number Optetrak Total Knee Exactech #K933610 Optetrak Total Knee Exactech #K954208 Nexgen Zimmer e Maxim Biomet =0 —eeemememeee- Durcon Total Stabilizer Howmedica ==mcmmmmmmem- Device Information: INDICATIONS…	Exactech, Inc.	1996	1

Also cleared against K933610: 9 other devices →

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150890	Exactech Optetrak Logic CC	Exactech, Inc.	2015	3

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?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K150890 (Exactech, Inc., 2015) has gone furthest, with 3 descendants of its own.
9 other devices also cite its predicate K933610.

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.

CAUTION: For cemented use only in the USA.

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/K012251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012251: Optetrak Total Knee System, Straight Stem Extensions - Additional Sizes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012251

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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