510(k) · Cleared

Cleared

Cardo Medical Align 360 Medialized Patella Component

K092803510(k) TraditionalCleared Dec 23, 2009103-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 Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Dec 23, 2009 as substantially equivalent to K073120 (Accelerated Innovation, LLC, 2008) and 1 other predicate after a 103-day review. Its family tree reaches back 2 generations to 1996.

Decided: Dec 23, 2009
Review: 103 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K962152 (1996). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK962152 Osteonics Scorpio Posteriorly Stabilized Total Knee SystemOsteonics Corp. · 1996 · Recalled
1 generation backK081127 Accin Total Knee SystemAccelerated Innovation, LLC · 2008 · Recalled
This deviceK092803 Cardo Medical Align 360 Medialized Patella ComponentCardo Medical Corp. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K962152	Osteonics Scorpio Posteriorly Stabilized Total Knee System	Osteonics Corp.	1996	13
−1	K081127	Accin Total Knee System	Accelerated Innovation, LLC	2008	1
0 (this device)	K092803	Cardo Medical Align 360 Medialized Patella Component	Cardo Medical Corp.	2009	—

Other ancestors by year cleared

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

FIG. 1 — Lineage of K092803, 1996–2009Source: 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
*	K073120	Accin Patellofemoral System Summary page 1 …, semi-constrained cemented polymer/metal/polymer, 21 CFR 888.3560, Class II. Predicate Device: Cardo Medical Dome Patella - K073120 (used with patellofemoral joint), Cardo Medical Dome Patella - K081 127 (used with Total Knee Syst…	Accelerated Innovation, LLC	2008	—
*	K081127	Accin Total Knee System Summary page 1 …ss II. Predicate Device: Cardo Medical Dome Patella - K073120 (used with patellofemoral joint), Cardo Medical Dome Patella - K081 127 (used with Total Knee System), and Scorpio Knee System - K9621 52 and K972967. Device Description…	Accelerated Innovation, LLC	2008	1
†	K962152	Osteonics Scorpio Posteriorly Stabilized Total Knee System	Osteonics Corp.	1996	13
†	K972967	Osteonics Scorpio Total Knee Universal Dome Patellar Component;Osteonics Scorpio Total…	Osteonics Corp.	1998	6

Also cleared against K073120: 3 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 13 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
4 of the 5 ancestors have a recall of any class.
3 other devices also cite its predicate K073120.

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. 2009, 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?

When used with the Patello-femoral System: The Cardo Medical Patellofemoral System patella components are for use in patellofemoral knee arthroplasty in patients with: * Degenerative arthritis in the distal femur and patella; * A history of patellar dislocation or fracture; * Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain deformity or dysfunction persists. When used with the Total Knee System: The Cardo…

Read the full statement (175 words)

When used with the Patello-femoral System:

The Cardo Medical Patellofemoral System patella components are for use in patellofemoral knee arthroplasty in patients with:

* Degenerative arthritis in the distal femur and patella;

* A history of patellar dislocation or fracture;

* Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain deformity or dysfunction persists.

When used with the Total Knee System:

The Cardo Medical Total Knee System patella components are for use in total knee arthroplasty as a result of:

* 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 procedure.

Additional indications for posteriorly stabilized components:

* Ligamentous instability requiring implant bearing surfaces with increased constraint;

* Absent or non-functioning posterior cruciate ligament.

The: patella components are single use only and intended for implantation with bone cement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092803 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092803: Cardo Medical Align 360 Medialized Patella Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092803

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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