510(k) · Cleared

Cleared

Optetrak 9MM Cruciate Retaining Tibial Insert, Slope ++

K082022510(k) SpecialCleared Sep 2, 200848-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 Sep 2, 2008 as substantially equivalent to K932690 (Exactech, Inc., 1995) after a 48-day review. Its family tree reaches back 1 generation to 1995. 13 later devices descend from it.

Decided: Sep 2, 2008
Review: 48 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K932690 (1995). 13 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK932690 Exactech Cruciate Retaining Cemented Total Knee SYExactech, Inc. · 1995 · Recalled
This deviceK082022 Optetrak 9MM Cruciate Retaining Tibial Insert, Slope ++Exactech, Inc. · 2008
Descendant · cites it directly · 12 of its ownK111400 Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 2011 · Recalled
Descendant · 2 generations on · 11 of its ownK121307 Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial…Exactech, Inc. · 2012
Descendant · 2 generations on · 7 of its ownK123687 Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013
Descendant · 2 generations on · 4 of its ownK153776 Optetrak One Logic Femoral ComponentsExactech, Inc. · 2016
Descendant · 2 generations on · 4 of its ownK123342 Optetrak Logic CRC Tibial InsertExactech, Inc. · 2013

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2011high 3 (2013) · low 0 (2019)2026

Most influential descendants

Showing 5 of 13 · See all

K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 2011 · cites it directly12descendants
K121307Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak…Exactech, Inc. · 2012 · 2 generations on11descendants
K123687Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013 · 2 generations on7descendants
K153776Optetrak One Logic Femoral ComponentsExactech, Inc. · 2016 · 2 generations on4descendants
K123342Optetrak Logic CRC Tibial InsertExactech, Inc. · 2013 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K932690	Exactech Cruciate Retaining Cemented Total Knee SY	Exactech, Inc.	1995	6
0 (this device)	K082022	Optetrak 9MM Cruciate Retaining Tibial Insert, Slope ++	Exactech, Inc.	2008	—
+1	K111400	Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component	Exactech, Inc.	2011	1
+2	K121307	Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size…	Exactech, Inc.	2012	—
+2	K123687	Optetrak Logic Porous Femoral Component	Exactech, Inc.	2013	—
+2	K153776	Optetrak One Logic Femoral Components	Exactech, Inc.	2016	—
+2	K123342	Optetrak Logic CRC Tibial Insert	Exactech, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2013	3	0
2014	1	0
2015	1	0
2016	2	0
2017	2	0
2018	1	0
2023	1	0

FIG. 1 — Lineage of K082022, 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? (1)

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 …nformation on devices to which substantial equivalence is claimed: 510(k) Trade or Proprietary or Model Name Manufacturer Number K932690 Optetrak® Cruciate Retaining Cemented Total Knee Exactech, Inc. System Indications fo…	Exactech, Inc.	1995	6

Also cleared against K932690: 5 other devices →

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K111400	Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component	Exactech, Inc.	2011	12

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?

Its one ancestor has a recall.
Of its descendants, K111400 (Exactech, Inc., 2011) has gone furthest, with 12 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. 2008, this device’s year, is highlighted.

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 Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, Qsteonecrosis, 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/K082022 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082022: Optetrak 9MM Cruciate Retaining Tibial Insert, Slope ++.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082022

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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