510(k) · Cleared

Cleared

Natural-Hip System Cocr Revision Stem

K970166510(k) TraditionalCleared Apr 8, 199782-day reviewClass II21 CFR 888.3353

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Intermedics Orthopedics · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Cleared on Apr 8, 1997 as substantially equivalent to K952859 (Johnson & Johnson Professionals, Inc., 1996) after an 82-day review. Its family tree reaches back 1 generation to 1996.

Decided: Apr 8, 1997
Review: 82 days
Class: Class II
Product code: LZO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K952859 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK952859 Ultima Cemented Long Stem Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
This deviceK970166 Natural-Hip System Cocr Revision StemIntermedics Orthopedics · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K952859	Ultima Cemented Long Stem Femoral Component	Johnson & Johnson Professionals, Inc.	1996	—
0 (this device)	K970166	Natural-Hip System Cocr Revision Stem	Intermedics Orthopedics	1997	—

FIG. 1 — Lineage of K970166, 1996–1997Source: 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 LZO? 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 LZO device

#1 K192827 Quadra-Pscore 19.3 · 10 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? (4)

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
*	K952859	Ultima Cemented Long Stem Femoral Component Summary page 2 …legally marketed devices: u Omnifit® Long Stem: Osteonics Corporation [510(k) number unknown to 10I]]. = Ultima® Long Stem: Johnson & Johnson Professional Inc. [510(k) K952859]. = PCA® Long Stem: Howmedica Inc. [510(k) number unknown to I0I]. = Matrix Cementra® Revision Femoral Stem: Smith & Nephew Ric…	Johnson & Johnson Professionals, Inc.	1996	—
*	—	Omnifit® Long Stem Named without a submission number			—
*	—	PCA® Long Stem Named without a submission number			—
*	—	Matrix Cementra® Revision Femoral Stem Named without a submission number			—

Also cleared against K952859: 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?

Its one ancestor has no recall.
1 other device also cites its predicate K952859.

How does its category compare?

All LZO devices

LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LZO

14in 2025

2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007high 279 (2022) · low 63 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LZO

1in 2025

2007high 42 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LZO

3,244in 2025

2007high 3,244 (2025) · low 125 (2008)2025

MAUDE reports naming product code LZO, 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	9	87	2	138
2008	11	63	13	125
2009	7	83	42	189
2010	15	78	0	394
2011	13	87	10	544
2012	14	98	14	963
2013	26	100	0	1,370
2014	13	85	1	1,477
2015	12	115	1	1,348
2016	10	177	9	1,728
2017	16	257	5	2,165
2018	18	163	2	3,133
2019	28	109	4	3,066
2020	18	112	3	1,963
2021	12	170	0	2,199
2022	11	279	4	1,985
2023	10	122	2	2,066
2024	11	111	1	2,586
2025	14	119	1	3,244
2026	9	102	0	—

What is it indicated for?

The Natural-Hip System CoCr Revision Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natural-Hip System CoCr Revision Stem is intended for cemented application only and is intended for single use only. The Natural-Hip System CoCr Revision Stem is intended for use in treatment of the following:

1. Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.

2. Those patients with failed previous surgery where pain, deformity or dysfunction persists.

3. Revision of previously failed arthroplasty.

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/K970166 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970166: Natural-Hip System Cocr Revision Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970166

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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