510(k) · Cleared

Cleared

Cardo Medical Femoral Cement Restrictor, Model 503-MCRX

K101032510(k) TraditionalCleared Jul 8, 201085-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

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

Cleared on Jul 8, 2010 as substantially equivalent to K032479 (Howmedica Osteonics Corp., 2003) and 1 other predicate after an 85-day review. Its family tree reaches back 2 generations to 1997.

Decided: Jul 8, 2010
Review: 85 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K970779 (1997). 6 ancestors in all, the oldest K962152 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK970779 Osteonics Tibial Tray Screw Hole PlugsOsteonics Corp. · 1997
1 generation backK032479 Howmedica Osteonics Tibial Tray Screw Hole PlugsHowmedica Osteonics Corp. · 2003
This deviceK101032 Cardo Medical Femoral Cement Restrictor, Model 503-MCRXCardo Medical, Inc. · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K970779	Osteonics Tibial Tray Screw Hole Plugs	Osteonics Corp.	1997	—
−1	K032479	Howmedica Osteonics Tibial Tray Screw Hole Plugs	Howmedica Osteonics Corp.	2003	—
0 (this device)	K101032	Cardo Medical Femoral Cement Restrictor, Model 503-MCRX	Cardo Medical, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0
1999	1	0
2008	1	0

FIG. 1 — Lineage of K101032, 1997–2010Source: 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? (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
*	K032479	Howmedica Osteonics Tibial Tray Screw Hole Plugs Summary page 1 …prosthesis, (21 CFR 888.3560, Product Code: JWH, Class 11) Predicate Device: Howmedica Osteonics Tibial Tray Screw Hole Plugs (K032479) Cardo Medical Inc. Total Knee System (K081127, cleared as ACCIN Total Knee…	Howmedica Osteonics Corp.	2003	—
*	K081127	Accin Total Knee System Summary page 1 …Class 11) Predicate Device: Howmedica Osteonics Tibial Tray Screw Hole Plugs (K032479) Cardo Medical Inc. Total Knee System (K081127, cleared as ACCIN Total Knee System) Device Description: The Cardo Medical Femoral Ce…	Accelerated Innovation, LLC	2008	1

Also cleared against K032479: 1 other device →

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 13 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
4 of the 6 ancestors have a recall of any class.
1 other device also cites its predicate K032479.

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. 2010, 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?

The Cardo Medical Total Knee System is indicated for use in individuals under going surgery for: * Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; * Post-traumatic loss of knee joint configuration and function * Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; * Revisions of previous…

Read the full statement (109 words)

The Cardo Medical Total Knee System is indicated for use in individuals under going surgery

for:

* Painful, disabling joint disease of the knee resulting from degenerative arthritis,

rheumatoid arthritis or post-traumatic arthritis;

* Post-traumatic loss of knee joint configuration and function

* Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be

returned to adequate function and stability;

* Revisions of previous unsuccessful knee replacement or other procedures.

Additional indications for posteriorly stabilized components:

* Ligamentous instability requiring implant bearing surfaces with increased constraint;

* Absent or non-functioning posterior cruciate ligament.

These devices are single use only and are intended for implantation with bone cement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101032 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101032: Cardo Medical Femoral Cement Restrictor, Model 503-MCRX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101032

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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