510(k) · Cleared

Cleared

Osteonics Scorpio Total Knee Relaxed Back P/S Tibial Bearing Insert

K991461510(k) SpecialCleared May 17, 199920-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

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

Cleared on May 17, 1999 as substantially equivalent to K962152 (Osteonics Corp., 1996) after a 20-day review. Its family tree reaches back 1 generation to 1996.

Decided: May 17, 1999
Review: 20 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962152 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK962152 Osteonics Scorpio Posteriorly Stabilized Total Knee SystemOsteonics Corp. · 1996 · Recalled
This deviceK991461 Osteonics Scorpio Total Knee Relaxed Back P/S Tibial Bearing InsertHowmedica Osteonics Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962152	Osteonics Scorpio Posteriorly Stabilized Total Knee System	Osteonics Corp.	1996	13
0 (this device)	K991461	Osteonics Scorpio Total Knee Relaxed Back P/S Tibial Bearing Insert	Howmedica Osteonics Corp.	1999	—

FIG. 1 — Lineage of K991461, 1996–1999Source: 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? (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
*	K962152	Osteonics Scorpio Posteriorly Stabilized Total Knee System Summary page 1 …steonics® predicate device, which has been cleared for marketing via the 510(k) process: ® Osteonics® Scorpio™ Total Knee Posteriorly Stabilized Tibial Bearing Insert (#K962152) Device Description The Osteonics® Scorpio™ Total Knee Relaxed Back P/S Tibial Bearing Insert is a modification of the predicat…	Osteonics Corp.	1996	13

Also cleared against K962152: 9 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?

Its one ancestor has a recall.
9 other devices also cite its predicate K962152.

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 indications for the use of the Osteonics® Scorpio™ Total Knee Relaxed Back P/S Tibial Bearing Insert, in keeping with those of other legally marketed Osteonics® total knee components, are as follows: Indications : . 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…

Read the full statement (108 words)

Indications :

. 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.

° Revision of previous unsuccessful knee replacement or other procedure.

. Ligamentous instability requiring implant bearing surface geometries with increased constraint.

. Absent or non-functioning posterior cruciate ligament.

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/K991461 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991461: Osteonics Scorpio Total Knee Relaxed Back P/S Tibial Bearing Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991461

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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