510(k) · Cleared

Cleared

Implex Continuum Patella-Revision Hedrocel Patella

K983835510(k) TraditionalCleared Mar 15, 1999136-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

Implex Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Mar 15, 1999 as substantially equivalent to K882322 (Buckman Co., Inc., 1989) and 2 other predicates after a 136-day review. Its family tree reaches back 2 generations to 1989.

Decided: Mar 15, 1999
Review: 136 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K882322 (1989). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK882322 Continuum Knee System (CKS)Buckman Co., Inc. · 1989
1 generation backK971789 Implex Continuum Porous PatellarImplex Corp. · 1997
This deviceK983835 Implex Continuum Patella-Revision Hedrocel PatellaImplex Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K882322	Continuum Knee System (CKS)	Buckman Co., Inc.	1989	—
−1	K971789	Implex Continuum Porous Patellar	Implex Corp.	1997	—
0 (this device)	K983835	Implex Continuum Patella-Revision Hedrocel Patella	Implex Corp.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1996	2	0

FIG. 1 — Lineage of K983835, 1989–1999Source: 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? (3)

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
*	K882322	Continuum Knee System (CKS) Summary page 1 …is, Patellar Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Patellar Component of Continuum Knee System (CKS), Implex Corp. (K882322); Continuum Porous Patella, Implex Corp. (K971879), Konstruct Patellar, Biomet, Inc. (K960856) The Revision Hedrocel® Patella is…	Buckman Co., Inc.	1989	—
*	K971789	Implex Continuum Porous Patellar Our OCR of the scanned summary read K971879, FDA’s number for Scanning Device Accessory for Use with the CB Erbium/2.94… (Continuum Biomedical, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Continuum Porous Patella, Implex Corp.”.	Implex Corp.	1997	—
*	K960856	Konstruct Patellar Component Summary page 1 …rosthesis Patellar Component of Continuum Knee System (CKS), Implex Corp. (K882322); Continuum Porous Patella, Implex Corp. (K971879), Konstruct Patellar, Biomet, Inc. (K960856) The Revision Hedrocel® Patella is a modular porous backed patella consisting of a Hedrocel® Patellar Backing with titanium allo…	Biomet, Inc.	1996	—

Also cleared against K882322: 2 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 10 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
None of the 5 ancestors has a recall.
2 other devices also cite its predicate K882322.

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?

The Implex Revision Hedrocel® Patella is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, ‘5) treatment of fractures that are unmanageable using other techniques, and 6) complications from failed prosthesis.

This device is intended for use with bone cement and supplemental fixation by means of suture attachment. Supplemental suture attachment may be used in cases where additional device support can be obtained.

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/K983835 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983835: Implex Continuum Patella-Revision Hedrocel Patella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983835

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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