510(k) · Cleared

Cleared

Smith & Nephew, Inc. Patient Matched Technology

K082358510(k) TraditionalCleared Nov 25, 200899-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 Nov 25, 2008 after a 99-day review. The FDA summary names its predicate without a number. 3 of the 429 devices in its family, counting itself, have a Class I recall. 428 later devices descend from it.

Decided: Nov 25, 2008
Review: 99 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 0

428 later devices descend from it, 8 citing it directly. 3 of the 429 devices in this family, counting this one, have a Class I recall.

This deviceK082358 Smith & Nephew, Inc. Patient Matched TechnologySmith & Nephew, Inc. · 2008
Descendant · cites it directly · 404 of its ownK093533 Zimmer Patient Specific Instruments System, Version 2.0Materialise NV · 2010
Descendant · 2 generations on · 314 of its ownK111492 Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer…Materialise NV · 2011 · Recalled
Descendant · 3 generations on · 251 of its ownK113666 Xia 3 Spinal SystemStryker Spine · 2012
Descendant · 2 generations on · 99 of its ownK102795 Signature Planner; Signature GuidesMaterialise NV · 2011 · Recalled
Descendant · 4 generations on · 93 of its ownK133350 Revere Stabilization SystemGlobus Medical, Inc. · 2014

Showing 5 of 428 descendants. See all descendants

Descendants cleared per year

2009high 55 (2023) · low 1 (2009)2026

Class I recalls in this family

K110533 Stryker Patient Specific Cutting Guidecites it directly · 2011
K122053 Shapematch Cutting Guide2 generations on · 2012
K211616 ExcelsiusHub6 generations on · 2021

Most influential descendants

Showing 5 of 428 · See all

K093533Zimmer Patient Specific Instruments System, Version 2.0Materialise NV · 2010 · cites it directly404descendants
K111492Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific InstrumentsMaterialise NV · 2011 · 2 generations on314descendants
K113666Xia 3 Spinal SystemStryker Spine · 2012 · 3 generations on251descendants
K102795Signature Planner; Signature GuidesMaterialise NV · 2011 · 2 generations on99descendants
K133350Revere Stabilization SystemGlobus Medical, Inc. · 2014 · 4 generations on93descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K082358	Smith & Nephew, Inc. Patient Matched Technology	Smith & Nephew, Inc.	2008	—
+1	K093533	Zimmer Patient Specific Instruments System, Version 2.0	Materialise NV	2010	—
+2	K111492	Zimmer Patient Specific Instruments Planner Model 2.5, Zimmer Patient Specific…	Materialise NV	2011	2
+3	K113666	Xia 3 Spinal System	Stryker Spine	2012	—
+2	K102795	Signature Planner; Signature Guides	Materialise NV	2011	4
+4	K133350	Revere Stabilization System	Globus Medical, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	2	0
2011	5	1
2012	9	1
2013	9	0
2014	9	0
2015	15	0
2016	11	0
2017	25	0
2018	22	0
2019	22	0
2020	34	0
2021	28	1
2022	36	0
2023	55	0
2024	51	0
2025	47	0
2026	47	0

FIG. 1 — Lineage of K082358, 2008–2026Source: 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.

3 devices in this family have a Class I recall. 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
*	—	Smith & Nephew, Inc.'s distal femoral cutting blocks Named without a submission number			—
*	—	Smith & Nephew, Inc.'s proximal tibial cutting blocks Named without a submission number			—

What descends from it? (428)

See all 428

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

Number	Device	Applicant	Decided	Descendants
K093533	Zimmer Patient Specific Instruments System, Version 2.0	Materialise NV	2010	404
K103136	Surgicase CMF, Surgicase Connect, Surgicase Guide	Materialise NV	2011	90
K093806	Myknee Cutting Blocks	Medacta International S.A.	2010	16
K110415	Signature Planner / Signature Guides	Materialise NV	2011	13
K130708	Smith & Nephew Patient Matched Cutting Blocks	Smith & Nephew, Inc.	2013	8
K172336	Smith & Nephew Patient Matched Cutting Blocks	Smith & Nephew, Inc.	2018	6
K110533	Stryker Patient Specific Cutting Guide Class I	Stryker Corp.	2011	3
K091263	Zimmer Patient Specific Instruments, Zimmer Patient Specific Instruments Planner, Model…	Materialise NV	2009	0

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K110533Stryker Patient Specific Cutting GuideStryker Corp. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K122053Shapematch Cutting GuideStryker Corp. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K093533 (Materialise NV, 2010) has gone furthest, with 404 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. 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?

Smith & Nephew's Patient Matched Cutting Blocks are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting.

The Patient Matched Cutting Blocks are intended for use with existing Smith & Nephew, Inc. knee systems and their cleared indications for use.

The Patient Matched Cutting Blocks are intended for single 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/K082358 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082358: Smith & Nephew, Inc. Patient Matched Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082358

Report an extraction error

Are you the manufacturer?

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