510(k) · Cleared
Recalled · Class II · 2017Optetrak Total Knee System Offset Tibial Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exactech, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Oct 17, 2002 as substantially equivalent to K933610 (Exactech, Inc., 1995) and 1 other predicate after a 23-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it. It has been recalled 34 times.
- Decided
- Oct 17, 2002
- Review
- 23 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 34
- Predicates
- 2
Its longest line of descent runs back 2 generations to K936079 (1994). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK023186 Optetrak Total Knee System Offset Tibial TrayExactech, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK071738 Exactech Optetrak Proximal Tibial SpacerExactech, Inc. · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K071738Exactech Optetrak Proximal Tibial SpacerExactech, Inc. · 2007 · cites it directly0descendants
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) | K023186 | Optetrak Total Knee System Offset Tibial Tray | Exactech, Inc. | 2002 | — |
| +1 | K071738 | Exactech Optetrak Proximal Tibial Spacer | Exactech, Inc. | 2007 | 2 |
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 |
|---|---|---|
| 2007 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K933610 | Exactech Cemented Total Knee System, Tibial ComponentsSummary page 1…s The device modifications presented in this Special 5 1O(k) represent changes to the Tibial Tray Components of the Optetrak Total Knee System (premarket notifications #K933610 and #KO1 1976). No changes were made to the other components of the Optetrak Total Knee System. The proposed device modification… | 1995 |
| * | K011976 | Optetrak Total Knee System Size 0/1 Delta (Line Extension) | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071738 | Exactech Optetrak Proximal Tibial Spacer | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2017 | Class II | Z-0128-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0131-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0132-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0145-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0147-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0149-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0153-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0159-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0126-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0135-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0138-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0139-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0142-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0143-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0150-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0156-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0157-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0127-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0129-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0130-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0133-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0134-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0136-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0137-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0140-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0151-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0152-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0154-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0141-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0144-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0146-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0148-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0155-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
| Sep 19, 2017 | Class II | Z-0158-2018 | Labeling design | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. |
The 5 latest of 34 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 6.9 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K071738 (Exactech, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K933610.
How does its category compare?
All JWH devicesJWH 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 andor 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/K023186 · printed Nov 5, 2026
Cite this page
510(k) Report. “K023186: Optetrak Total Knee System Offset Tibial Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023186
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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