510(k) · Cleared

Recalled · Class II · 2020

Disposable Cement Spacer Molds for Temporary Knee Prostheses

K050210510(k) TraditionalCleared Jul 19, 2005172-day reviewClass II21 CFR 888.3560Recalls 8

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

Biomet, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jul 19, 2005 as substantially equivalent to K032522 (Exactech, Inc., 2004) after a 172-day review. Its family tree reaches back 2 generations to 1995. 24 later devices descend from it. It has been recalled 8 times.

Decided: Jul 19, 2005
Review: 172 days
Class: Class II
Product code: JWH
Recalls: 8
Predicates: 1

Its longest line of descent runs back 2 generations to K936159 (1995). 24 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
1 generation backK032522 Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc. · 2004
This deviceK050210 Disposable Cement Spacer Molds for Temporary Knee ProsthesesBiomet, Inc. · 2005
Descendant · cites it directly · 20 of its ownK062274 Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021…Tecres S.P.A. · 2008
Descendant · 2 generations on · 19 of its ownK101356 Spacer-G and Spacer-KTecres S.P.A. · 2011
Descendant · 3 generations on · 16 of its ownK112470 2GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012
Descendant · 4 generations on · 5 of its ownK183017 Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019
Descendant · 4 generations on · 5 of its ownK173967 Remedy Acetabular CupOsteoremedies, LLC · 2018

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2008high 5 (2019) · low 0 (2009)2026

Most influential descendants

Showing 5 of 24 · See all

K062274Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321Tecres S.P.A. · 2008 · cites it directly20descendants
K101356Spacer-G and Spacer-KTecres S.P.A. · 2011 · 2 generations on19descendants
K1124702GC Hip/Knee Modular SpacerMandell Horwitz Consultants, LLC · 2012 · 3 generations on16descendants
K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee SpacerOsteoremedies, LLC · 2019 · 4 generations on5descendants
K173967Remedy Acetabular CupOsteoremedies, LLC · 2018 · 4 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K936159	Natural-Knee II System	Intermedics Orthopedics	1995	6
−1	K032522	Tecres Spacer-K Temporary Knee Prosthesis	Exactech, Inc.	2004	—
0 (this device)	K050210	Disposable Cement Spacer Molds for Temporary Knee Prostheses	Biomet, Inc.	2005	—
+1	K062274	Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121…	Tecres S.P.A.	2008	—
+2	K101356	Spacer-G and Spacer-K	Tecres S.P.A.	2011	—
+3	K112470	2GC Hip/Knee Modular Spacer	Mandell Horwitz Consultants, LLC	2012	—
+4	K183017	Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer	Osteoremedies, LLC	2019	—
+4	K173967	Remedy Acetabular Cup	Osteoremedies, LLC	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0
2012	1	0
2014	1	0
2017	1	0
2018	1	0
2019	5	0
2020	2	0
2022	2	0
2023	2	0
2024	3	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K050210, 1995–2026Source: 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? (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
*	K032522	Tecres Spacer-K Temporary Knee Prosthesis Summary page 1 …ed, cemented prosthesis (21 CFR 888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Spacer-K Temporary Knee Prosthesis cleared by the FDA in K032522 and marketed by Exactech, Inc., Gainesville, FL. Device Description: The femoral cement spacer molds are offered in four sizes (…	Exactech, Inc.	2004	—

Also cleared against K032522: 2 other devices →

What descends from it? (24)

See all 24

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

Number	Device	Applicant	Decided	Descendants
K062274	Spacer-K Temporary Knee Spacer with Gentamicin, Models SPK0021, SPK0121, SPK0221, SPK0321	Tecres S.P.A.	2008	20
K161273	StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis	Biomet, Inc.	2017	3
K133449	Kasm Knee Articulating Spacer Molds	Ortho Development Corp.	2014	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 26, 2020	Class II	Z-1664-2020	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Feb 26, 2020	Class II	Z-1669-2020	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Feb 26, 2020	Class II	Z-1663-2020	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Feb 26, 2020	Class II	Z-1665-2020	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Feb 26, 2020	Class II	Z-1667-2020	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Feb 26, 2020	Class II	Z-1662-2020	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Feb 26, 2020	Class II	Z-1668-2020	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Feb 26, 2020	Class II	Z-1666-2020	Process control	Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

The 5 latest of 8 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 10 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
1 of the 2 ancestors has a recall of any class.
Of its descendants, K062274 (Tecres S.P.A., 2008) has gone furthest, with 20 descendants of its own.
2 other devices also cite its predicate K032522.

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?

Disposable cement spacer molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee prosthesis is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (gentamicin/polymethylmethacrylate), the molded temporary prosthesis is indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050210 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050210: Disposable Cement Spacer Molds for Temporary Knee Prostheses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050210

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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