510(k) · Cleared

Recalled · Class II · 2023

Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, HI-Flex Posterior-Stabi

K033883510(k) SpecialCleared Feb 13, 200460-day reviewClass II21 CFR 888.3560Recalls 3

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 Feb 13, 2004 as substantially equivalent to K933610 (Exactech, Inc., 1995) and 3 other predicates after a 60-day review. Its family tree reaches back 3 generations to 1994. 17 later devices descend from it. It has been recalled 3 times.

Decided: Feb 13, 2004
Review: 60 days
Class: Class II
Product code: JWH
Recalls: 3
Predicates: 4

Its longest line of descent runs back 3 generations to K936079 (1994). 10 ancestors in all. 17 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
2 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
1 generation backK032606 Optetrak Total Knee System Asymmetric Femoral Components Size 6…Exactech, Inc. · 2003
This deviceK033883 Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized…Exactech, Inc. · 2004
Descendant · cites it directly · 15 of its ownK093360 Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…Exactech, Inc. · 2010 · Recalled
Descendant · 2 generations on · 12 of its ownK111400 Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 2011 · Recalled
Descendant · 3 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

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2007high 3 (2013) · low 0 (2008)2026

Most influential descendants

Showing 5 of 17 · See all

K093360Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5TExactech, Inc. · 2010 · cites it directly15descendants
K111400Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral ComponentExactech, Inc. · 2011 · 2 generations on12descendants
K121307Optetrak Logic CR Tibial Insert, Size 0 Optetrak Logic CR Tibial Insert, Size 6 Optetrak…Exactech, Inc. · 2012 · 3 generations on11descendants
K123687Optetrak Logic Porous Femoral ComponentExactech, Inc. · 2013 · 2 generations on7descendants
K153776Optetrak One Logic Femoral ComponentsExactech, Inc. · 2016 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K936079	Ecactech Porous Coated Finned Tibial Tray Compnent	Exactech, Inc.	1994	—
−2	K011976	Optetrak Total Knee System Size 0/1 Delta (Line Extension)	Exactech, Inc.	2001	—
−1	K032606	Optetrak Total Knee System Asymmetric Femoral Components Size 6…	Exactech, Inc.	2003	—
0 (this device)	K033883	Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented…	Exactech, Inc.	2004	—
+1	K093360	Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes…	Exactech, Inc.	2010	2
+2	K111400	Optetrak Logic CR Tibial Insert, Optetrak Logic CR Femoral Component	Exactech, Inc.	2011	1
+3	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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	2	0
1995	3	0
1996	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2010	1	0
2011	2	0
2012	1	0
2013	3	0
2014	1	0
2015	2	0
2016	2	0
2017	2	0
2018	1	0
2023	1	0

FIG. 1 — Lineage of K033883, 1994–2023Source: 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

Get a 510(k) Report

What was it cleared against? (4)

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 …ce Comparison: Model 510(k) Number Optetrak® Total Knee System Tibial Component K933610 Optetrak® Size 0 and 1 Delta Line Extension K01 1976 Optetrak® Total Knee Asymmetric Femoral Components…	Exactech, Inc.	1995	7
*	K011976	Optetrak Total Knee System Size 0/1 Delta (Line Extension) Summary page 2 …510(k) Number Optetrak® Total Knee System Tibial Component K933610 Optetrak® Size 0 and 1 Delta Line Extension K01 1976 Optetrak® Total Knee Asymmetric Femoral Components K032606 Optetrak® B-Series Total Knee System…	Exactech, Inc.	2001	—
*	K032606	Optetrak Total Knee System Asymmetric Femoral Components Size 6 Psoterior-Stabilizing… Summary page 2 …K933610 Optetrak® Size 0 and 1 Delta Line Extension K01 1976 Optetrak® Total Knee Asymmetric Femoral Components K032606 Optetrak® B-Series Total Knee System K010434 Device Information: INTENDED USE The Optetrak® H…	Exactech, Inc.	2003	—
*	K010434	Optetrak B-Series Total Knee System Summary page 2 …K01 1976 Optetrak® Total Knee Asymmetric Femoral Components K032606 Optetrak® B-Series Total Knee System K010434 Device Information: INTENDED USE The Optetrak® HI-FLEX Asymmetric Posterior-Stabilized Cemented Femoral Components (herein ref…	Exactech, Inc.	2001	1

Also cleared against K933610: 9 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K093360	Optetrak Logic Total Knee System Trapezoidal Tibial Tray, Sizes 2.5F/1.5T-3.5F/4.5T	Exactech, Inc.	2010	15
K071738	Exactech Optetrak Proximal Tibial Spacer	Exactech, Inc.	2007	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 21, 2023	Class II	Z-0584-2024	Packaging change control	Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
Aug 30, 2021	Class II	Z-0021-2022	Process control	Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Oct 9, 2014	Class II	Z-0906-2015	Labeling mix-ups	Mislabeled

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
6 of the 10 ancestors have a recall of any class.
Of its descendants, K093360 (Exactech, Inc., 2010) has gone furthest, with 15 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. The OPTETRAK® Total Knee Systems are contraindicated in patients with…

Read the full statement (144 words)

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.

The OPTETRAK® Total Knee Systems are contraindicated in patients with active

infection, patients without sufficient bone stock to allow appropriate insertion and

fixation of the prosthesis, patients without sufficient soft tissue integrity to provide

adequate stability, and in patients with either mental or neuromuscular disorders that do

not allow control of the knee joint, and in patients whose weight, age, or activity level

might cause extreme loads and early failure of the system.

OPTETRAK® HI-FLEx Tibial Inserts must be used with Optetrak® Hi-FLEX Femoral

Components.

CA UTION: In the USA, for cemented use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033883 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033883: Optetrak Total Knee System, HI-Flex Asymmetric Posterior-Stabilized Cemented Femoral Components, HI-Flex Posterior-Stabi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033883

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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