510(k) · Cleared

Recalled · 2010

Advance Modular Tibial Component

K973524510(k) TraditionalCleared Dec 12, 199786-day reviewClass II21 CFR 888.3560Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Dec 12, 1997 after an 86-day review. The FDA summary names its predicate without a number. 8 later devices descend from it. It has been recalled once.

Decided: Dec 12, 1997
Review: 86 days
Class: Class II
Product code: JWH
Recalls: 1
Predicates: 0

8 later devices descend from it, 2 citing it directly.

This deviceK973524 Advance Modular Tibial ComponentWrightmedicaltechnologyinc · 1997
Descendant · cites it directly · 6 of its ownK161520 ELEOS Limb Salvage SystemOnkos Surgical, Inc. · 2016 · Recalled
Descendant · 2 generations on · 1 of its ownK203090 ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical · 2020
Descendant · 2 generations on · 0 of its ownK253066 ELEOS™ with NanoCept® Technology Limb Salvage SystemOnkos Surgical, Inc. · 2026
Descendant · 2 generations on · 0 of its ownK252920 ELEOS™ Limb Salvage System with NanoCept® TechnologyOnkos Surgical, Inc. · 2025
Descendant · 2 generations on · 0 of its ownK211677 ELEOS Limb Salvage SystemOnkos Surgical · 2021

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2016high 3 (2021) · low 0 (2017)2026

Most influential descendants

Showing 5 of 8 · See all

K161520ELEOS Limb Salvage SystemOnkos Surgical, Inc. · 2016 · cites it directly6descendants
K203090ELEOS Limb Salvage System featuring BIOGRIPOnkos Surgical · 2020 · 2 generations on1descendant
K253066ELEOS™ with NanoCept® Technology Limb Salvage SystemOnkos Surgical, Inc. · 2026 · 2 generations on0descendants
K252920ELEOS™ Limb Salvage System with NanoCept® TechnologyOnkos Surgical, Inc. · 2025 · 2 generations on0descendants
K211677ELEOS Limb Salvage SystemOnkos Surgical · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K973524	Advance Modular Tibial Component	Wrightmedicaltechnologyinc	1997	—
+1	K161520	ELEOS Limb Salvage System	Onkos Surgical, Inc.	2016	11
+2	K203090	ELEOS Limb Salvage System featuring BIOGRIP	Onkos Surgical	2020	—
+2	K253066	ELEOS™ with NanoCept® Technology Limb Salvage System	Onkos Surgical, Inc.	2026	—
+2	K252920	ELEOS™ Limb Salvage System with NanoCept® Technology	Onkos Surgical, Inc.	2025	—
+2	K211677	ELEOS Limb Salvage System	Onkos Surgical	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	2	0
2020	1	0
2021	3	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K973524, 1997–2026Source: 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? (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
*	—	AXIOM® Modular Tibial Component Named without a submission number			—
*	—	ADVANCE® Cobalt Chrome Tibial Component Named without a submission number			—

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K161520	ELEOS Limb Salvage System	Onkos Surgical, Inc.	2016	6
K152631	MPO Total Knee Systems MR Labeling	Microport Orthopedics, Inc.	2016	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 19, 2010	Not classified	Z-1215-2010	Employee error	The product contained screws with the incorrect length (incorrectly contained 15 mm length screws instead of the correct 5 mm length screws).

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K161520 (Onkos Surgical, Inc., 2016) has gone furthest, with 6 descendants of its own.

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?

Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

2) inflammatory degenerative Jomt disease including rheumatoid arthritis;

3) correction of functional deformity;

4) revision procedures where other treatments or devices have failed; and

5) treatment of fractures that are unmanageable using other techniques.

For cemented use only.

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/K973524 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973524: Advance Modular Tibial Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973524

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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