510(k) · Cleared

Cleared

Modification to Scorpio NRG Knee System

K071991510(k) SpecialCleared Aug 15, 200726-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 Aug 15, 2007 as substantially equivalent to K042343 (Howmedica Osteonics Corp., 2005) and 1 other predicate after a 26-day review. Its family tree reaches back 1 generation to 2003. 29 later devices descend from it.

Decided: Aug 15, 2007
Review: 26 days
Class: Class II
Product code: JWH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K030978 (2003). 2 ancestors in all. 29 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK030978 Scorpio NRG Knee SystemHowmedica Osteonics Corp. · 2003 · Recalled
This deviceK071991 Modification to Scorpio NRG Knee SystemHowmedica Osteonics Corp. · 2007
Descendant · cites it directly · 15 of its ownK082019 Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009
Descendant · cites it directly · 8 of its ownK103733 United U2 Xpe Total Knee SystemUnited Orthopedic Corporation · 2011 · Recalled
Descendant · 2 generations on · 7 of its ownK091280 Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009
Descendant · 2 generations on · 6 of its ownK131481 Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014
Descendant · 2 generations on · 5 of its ownK132752 Ultracongruent InsertUnited Orthopedic Corporation · 2014

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2009high 4 (2017) · low 0 (2010)2026

Most influential descendants

Showing 5 of 29 · See all

K082019Freedom Total Knee SystemMaxx Orthopedics, Inc. · 2009 · cites it directly15descendants
K103733United U2 Xpe Total Knee SystemUnited Orthopedic Corporation · 2011 · cites it directly8descendants
K091280Freedom Total Knee Cruciate Retaining (CR) Femoral ComponentMaxx Orthopedics, Inc. · 2009 · 2 generations on7descendants
K131481Freedom PCK ComponentsMaxx Orthopedics, Inc. · 2014 · 2 generations on6descendants
K132752Ultracongruent InsertUnited Orthopedic Corporation · 2014 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K030978	Scorpio NRG Knee System	Howmedica Osteonics Corp.	2003	11
0 (this device)	K071991	Modification to Scorpio NRG Knee System	Howmedica Osteonics Corp.	2007	—
+1	K082019	Freedom Total Knee System	Maxx Orthopedics, Inc.	2009	—
+1	K103733	United U2 Xpe Total Knee System	United Orthopedic Corporation	2011	2
+2	K091280	Freedom Total Knee Cruciate Retaining (CR) Femoral Component	Maxx Orthopedics, Inc.	2009	—
+2	K131481	Freedom PCK Components	Maxx Orthopedics, Inc.	2014	—
+2	K132752	Ultracongruent Insert	United Orthopedic Corporation	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2011	1	0
2014	3	0
2015	2	0
2016	2	0
2017	4	0
2019	1	0
2020	3	0
2021	3	0
2022	2	0
2023	1	0
2024	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K071991, 2003–2026Source: 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
*	K042343	Scorpio NRG Knee System Summary page 2 …nd are intended for implantation with bone cement. Substantial Equivalence: The subject Scorpio NRG X3 inserts are a modification to the Scorpio NRG System cleared in K042343 [Scorpio NRG Knee System (Cruciate Retaining Components)] and K030978 (Scorpio NRG Knee System Posterior Stabilized). The determi…	Howmedica Osteonics Corp.	2005	1
*	K030978	Scorpio NRG Knee System Summary page 2 …alence: The subject Scorpio NRG X3 inserts are a modification to the Scorpio NRG System cleared in K042343 [Scorpio NRG Knee System (Cruciate Retaining Components)] and K030978 (Scorpio NRG Knee System Posterior Stabilized). The determination of the substantial equivalence for the Scorpio NRG X3 inserts i…	Howmedica Osteonics Corp.	2003	11

Also cleared against K042343: 7 other devices →

What descends from it? (29)

See all 29

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K082019	Freedom Total Knee System	Maxx Orthopedics, Inc.	2009	15
K103733	United U2 Xpe Total Knee System	United Orthopedic Corporation	2011	8
K200395	LOSPA II Knee System (EXULT Knee Replacement System)	Corentec Co., Ltd.	2020	2
K161414	Anatomic Total Knee System	Amplitude	2017	1
K192084	Madison Total Knee System	Implanet, S.A.	2019	0

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?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K082019 (Maxx Orthopedics, Inc., 2009) has gone furthest, with 15 descendants of its own.
7 other devices also cite its predicate K042343.

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. 2007, 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 Scorpio® NRG® Knee System 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; · Revision of previous…

Read the full statement (111 words)

The Scorpio® NRG® Knee System 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;

· Revision of previous unsuccessful knee replacement or other procedure;

Additional Indications for Posterior Stabilized Components:

* Ligamentous instability requiring implant bearing surface geometries with increased constraint

* Absent or non-functioning posterior cruciate ligament

These components 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/K071991 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071991: Modification to Scorpio NRG Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071991

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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