510(k) · Cleared

Cleared

Cellbrick Knee Spacer

K243024510(k) TraditionalCleared Dec 20, 202484-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

United Orthopedic Corporation · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Dec 20, 2024 as substantially equivalent to K222570 (Heraeus Medical GmbH, 2023) after an 84-day review. Its family tree reaches back 3 generations to 1995.

Decided: Dec 20, 2024
Review: 84 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K936159 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK936159 Natural-Knee II SystemIntermedics Orthopedics · 1995 · Recalled
2 generations backK032522 Tecres Spacer-K Temporary Knee ProsthesisExactech, Inc. · 2004
1 generation backK222570 COPAL knee mouldsHeraeus Medical GmbH · 2023
This deviceK243024 Cellbrick Knee SpacerUnited Orthopedic Corporation · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K936159	Natural-Knee II System	Intermedics Orthopedics	1995	6
−2	K032522	Tecres Spacer-K Temporary Knee Prosthesis	Exactech, Inc.	2004	—
−1	K222570	COPAL knee moulds	Heraeus Medical GmbH	2023	—
0 (this device)	K243024	Cellbrick Knee Spacer	United Orthopedic Corporation	2024	—

FIG. 1 — Lineage of K243024, 1995–2024Source: 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
*	K222570	COPAL knee moulds Summary page 5 …888.3560 Product Codes JWH Predicate Device Information 510(k) Number Predicate Trade Name Product Code Primary Predicate K222570 COPAL® knee moulds JWH Predicate or Reference Devices K101356 Spacer-K…	Heraeus Medical GmbH	2023	—
†	K101356	Spacer-G and Spacer-K	Tecres S.P.A.	2011	—
†	K181732	InterSpace Knee Extra-Large Size, InterSpace Knee ATS	Tecres S.P.A.	2019	—
†	K183017	Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer	Osteoremedies, LLC	2019	—
†	K140073	U2 Femoral Component, CR, Cemented	United Orthopedic Corp.	2014	—
†	K132752	Ultracongruent Insert	United Orthopedic Corporation	2014	—
†	K150829	U2 Total Knee System- Additional Sizes	United Orthopedic Corporation	2015	—
†	K222700	Tibial baseplate, Tibial insert	United Orthopedic Corporation	2022	—

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 29 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
1 of the 3 ancestors has a recall of any class.

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. 2024, 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?

This product is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. This product is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). During the implantation period, patients have to use…

Read the full statement (110 words)

This product is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process.

This product is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.). During the implantation period, patients have to use traditional mobility assist devices (e.g. crutches, walkers, canes) for daily activities.

With pre-clinical validations of antibiotic elution, tibial spacer fatigue test, and knee spacer wear test, only Palacos MV+G bone cement may be used for preparing the spacers.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K243024 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243024: Cellbrick Knee Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243024

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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