510(k) · Cleared

Cleared

Revision Prothesis

K110837510(k) SpecialCleared Apr 22, 201128-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

Smith & Nephew, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Apr 22, 2011 as substantially equivalent to K042515 (Smith & Nephew, Inc., 2005) after a 28-day review. Its family tree reaches back 2 generations to 1995.

Decided: Apr 22, 2011
Review: 28 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K951987 (1995). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK951987 Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 1995 · Recalled
1 generation backK042515 Smith & Nephew, Inc. High Performance KneeSmith & Nephew, Inc. · 2005 · Recalled
This deviceK110837 Revision ProthesisSmith & Nephew, Inc. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K951987	Genesis II Total Knee System	Smith & Nephew Richards, Inc.	1995	6
−1	K042515	Smith & Nephew, Inc. High Performance Knee	Smith & Nephew, Inc.	2005	3
0 (this device)	K110837	Revision Prothesis	Smith & Nephew, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1999	1	0

FIG. 1 — Lineage of K110837, 1995–2011Source: 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
*	K042515	Smith & Nephew, Inc. High Performance Knee Summary page 1 …Device Description Subject of this premarket notification is a review of changes to the High Performance Knee (previously cleared for market via premarket notification K042515)1 t result in the Revision Journey ECS STD Inserts. The subject devices are articular inserts manufactured from UHMWPE material.…	Smith & Nephew, Inc.	2005	3

Also cleared against K042515: 11 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
4 of the 4 ancestors have a recall of any class.
11 other devices also cite its predicate K042515.

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. 2011, 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?

Total knee components are indicated for:

1. Rheumatoid arthritis

2. Post-traumatic arthritis, ost~oarhritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.

3. Failed osteotomies, unicomparimental replacement, or total knee replacement.

4. The posterior-stabilized knee system is designed for use in patients in primary and revision-surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain Intact.

The Journey BCS STID Inserts are indicated for use without bone cement, and are single use devices.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110837 · printed Nov 5, 2026

Cite this page

510(k) Report. “K110837: Revision Prothesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110837

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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