510(k) Report

510(k) · Cleared

Cleared

Natural Hip System Porous Stem - Collarless, Collared

K963266510(k) TraditionalCleared Oct 15, 199656-day reviewClass II21 CFR 888.3358

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

Intermedics Orthopedics · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Cleared on Oct 15, 1996 as substantially equivalent to K913060 (Intermedics Orthopedics, 1991) and 2 other predicates after a 56-day review. Its family tree reaches back 2 generations to 1993.

Decided
Oct 15, 1996
Review
56 days
Class
Class II
Product code
LPH
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K915787 (1993). 3 ancestors in all, the oldest K913060 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1991: 1 other ancestorK915787 · Stability Hip Stem with Porocoat · Depuy, Inc. · 1993K934457 · Stability Hip Stem with Porocoat · Depuy, Inc. · 199419901992199419961998
Other ancestors, by generation 1 generation back: 1 other ancestor K934457 · Stability Hip Stem with Porocoat · Depuy, Inc. · 1994K915787 · Stability Hip Stem with Porocoat · Depuy, Inc. · 19930
  1. Root · 2 generations backK915787 Stability Hip Stem with PorocoatDepuy, Inc. · 1993
  2. 1 generation backK934457 Stability Hip Stem with PorocoatDepuy, Inc. · 1994
  3. This deviceK963266 Natural Hip System Porous Stem - Collarless, CollaredIntermedics Orthopedics · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K915787Stability Hip Stem with PorocoatDepuy, Inc.1993—
−1K934457Stability Hip Stem with PorocoatDepuy, Inc.1994—
0 (this device)K963266Natural Hip System Porous Stem - Collarless, CollaredIntermedics Orthopedics1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
FIG. 1 — Lineage of K963266, 1993–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 LPH? 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 LPH device

  1. #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K913060Natural Porous Hip System
Summary page 1
…re substantially equivalent to the features employed by the following predicate legally marketed devices: Porous Natural Hip Stem: Intermedics Orthopedics, Inc. (510(k) K913060). Stability Hip Stem: Depuy Inc. (510(k)s K915787 and K934457). Device Description: The Natural Hip System Poro…
Intermedics Orthopedics1991—
*K915787Stability Hip Stem with Porocoat
Summary page 1
…d by the following predicate legally marketed devices: Porous Natural Hip Stem: Intermedics Orthopedics, Inc. (510(k) K913060). Stability Hip Stem: Depuy Inc. (510(k)s K915787 and K934457). Device Description: The Natural Hip System Porous Stem is identical in design geometry as compared…
Depuy, Inc.1993—
*K934457Stability Hip Stem with Porocoat
Summary page 1
…lowing predicate legally marketed devices: Porous Natural Hip Stem: Intermedics Orthopedics, Inc. (510(k) K913060). Stability Hip Stem: Depuy Inc. (510(k)s K915787 and K934457). Device Description: The Natural Hip System Porous Stem is identical in design geometry as compared to the pred…
Depuy, Inc.1994—

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 3 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
  • None of the 3 ancestors has a recall.

How does its category compare?

All LPH devices

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

FDA decisions per year · LPH

12in 2025

2007: 102008: 102009: 32010: 152011: 162012: 252013: 112014: 202015: 182016: 102017: 122018: 92019: 222020: 72021: 82022: 142023: 102024: 62025: 122026 (partial year): 8
2007high 25 (2012) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPH

153in 2025

2007: 116 days median2008: 86 days median2009: 112 days median2010: 100 days median2011: 110 days median2012: 76 days median2013: 135 days median2014: 129 days median2015: 111 days median2016: 150 days median2017: 121 days median2018: 145 days median2019: 164 days median2020: 164 days median2021: 410 days median2022: 247 days median2023: 111 days median2024: 92 days median2025: 153 days median2026 (partial year): 256 days median
2007high 410 (2021) · low 76 (2012)2026

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

Recalls per year · LPH

4in 2025

2007: 162008: 12009: 22010: 222011: 262012: 302013: 92014: 32015: 12016: 82017: 142018: 22019: 82020: 62021: 42022: 22023: 22024: 12025: 42026 (partial year): 2
2007high 30 (2012) · low 1 (2008)2026

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

Adverse event reports per year · LPH

6,163in 2025

2007: 5092008: 7062009: 1,1562010: 2,0072011: 3,3202012: 3,7852013: 5,0022014: 5,1632015: 5,8302016: 4,9002017: 5,3122018: 5,9542019: 7,1302020: 5,4292021: 5,9782022: 5,2232023: 5,3452024: 5,6262025: 6,163
2007high 7,130 (2019) · low 509 (2007)2025

MAUDE reports naming product code LPH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071011616509
200810861706
2009311221,156
201015100222,007
201116110263,320
20122576303,785
20131113595,002
20142012935,163
20151811115,830
20161015084,900
201712121145,312
2018914525,954
20192216487,130
2020716465,429
2021841045,978
20221424725,223
20231011125,345
202469215,626
20251215346,163
202682562—

More from Intermedics Orthopedics

108 FDA decisions under this applicant name. See the company

  • K970300Natural-Hip System Porous Stem with HA/CstiIntermedics Orthopedics · 1997
  • K970498Natural-Knee II Revision Femoral Spacer LugsIntermedics Orthopedics · 1997
  • K970166Natural-Hip System Cocr Revision StemIntermedics Orthopedics · 1997
  • K970567Select Shoulder Curved-Back Pegged All Poly GlenoidsIntermedics Orthopedics · 1997
  • K964357Natural-Hip System Cocr StemIntermedics Orthopedics · 1997

Recent decisions in LPH

The LPH category page

  • K261453G7® Acetabular SystemZimmer Biomet · 2026
  • K253630Mpact 3D Metal FoamMedacta International S.A. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 20262 recalls
  • K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC · 2026

https://510kreport.com/device/K963266 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963266: Natural Hip System Porous Stem - Collarless, Collared.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963266

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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