510(k) Report

510(k) · Cleared

Cleared

Natural-Hip System - Calcar Replacement Hip Stem

K961727510(k) TraditionalCleared Jul 19, 199677-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 Jul 19, 1996 as substantially equivalent to K945516 (Intermedics Orthopedics, 1995) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1990.

Decided
Jul 19, 1996
Review
77 days
Class
Class II
Product code
LZO
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K902712 (1990). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestorReference device: K923934 · TX-3 SD · Skylark Device Co., Ltd. · 1992Reference device: K942330 · Apr II Femoral Component (Various) · Intermedics Orthopedics · 1994K902712 · Osteonics PS Head and Neck Hip Stem Series · Osteonics Corp. · 199019901992199419961998
Other ancestors, by generation 1 generation back: 1 other ancestor K902712 · Osteonics PS Head and Neck Hip Stem Series · Osteonics Corp. · 19900
  1. Root · 1 generation backK902712 Osteonics PS Head and Neck Hip Stem SeriesOsteonics Corp. · 1990
  2. This deviceK961727 Natural-Hip System - Calcar Replacement Hip StemIntermedics Orthopedics · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K902712Osteonics PS Head and Neck Hip Stem SeriesOsteonics Corp.1990—
0 (this device)K961727Natural-Hip System - Calcar Replacement Hip StemIntermedics Orthopedics1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
FIG. 1 — Lineage of K961727, 1990–1996Source: 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 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. #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K945516Natural-Hip (TM) System - Calcar Replcement Stem
Summary page 1
…eplacement Hip Stem are substantially equivalent to the features employed by the following predicate legally marketed devices: > Calcar Replacement Stem: IOI - (510(k) #K945516); > Omnifit Head/Neck Hip Stem: Osteonics Corporation (510(k) No. unknown to IOI); > HNR (Head and Neck Replacement) Stem: Howm…
Intermedics Orthopedics1995—
*K902712Osteonics PS Head and Neck Hip Stem Series
Summary page 1
…) #K945516); > Omnifit Head/Neck Hip Stem: Osteonics Corporation (510(k) No. unknown to IOI); > HNR (Head and Neck Replacement) Stem: Howmedica Corporation (510(k) No. K902712); and > Cemented Calcar Stem: Depuy Inc. (510(k) No. unknown 0 I0I); Device Description: Intended Use: The Ca…
Osteonics Corp.1990—
*—Omnifit Head/Neck Hip Stem
Named without a submission number
—
*—Cemented Calcar Stem
Named without a submission number
—
†K923934TX-3 SDSkylark Device Co., Ltd.1992—
†K942330Apr II Femoral Component (Various)Intermedics Orthopedics1994—

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?

  • None of the 2 ancestors has a recall.

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

2007: 92008: 112009: 72010: 152011: 132012: 142013: 262014: 132015: 122016: 102017: 162018: 182019: 282020: 182021: 122022: 112023: 102024: 112025: 142026 (partial year): 9
2007high 28 (2019) · low 7 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LZO

119in 2025

2007: 87 days median2008: 63 days median2009: 83 days median2010: 78 days median2011: 87 days median2012: 98 days median2013: 100 days median2014: 85 days median2015: 115 days median2016: 177 days median2017: 257 days median2018: 163 days median2019: 109 days median2020: 112 days median2021: 170 days median2022: 279 days median2023: 122 days median2024: 111 days median2025: 119 days median2026 (partial year): 102 days median
2007high 279 (2022) · low 63 (2008)2026

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

Recalls per year · LZO

1in 2025

2007: 22008: 132009: 422011: 102012: 142014: 12015: 12016: 92017: 52018: 22019: 42020: 32022: 42023: 22024: 12025: 1
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

2007: 1382008: 1252009: 1892010: 3942011: 5442012: 9632013: 1,3702014: 1,4772015: 1,3482016: 1,7282017: 2,1652018: 3,1332019: 3,0662020: 1,9632021: 2,1992022: 1,9852023: 2,0662024: 2,5862025: 3,244
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079872138
2008116313125
200978342189
201015780394
2011138710544
2012149814963
20132610001,370
2014138511,477
20151211511,348
20161017791,728
20171625752,165
20181816323,133
20192810943,066
20201811231,963
20211217002,199
20221127941,985
20231012222,066
20241111112,586
20251411913,244
202691020—

What is it indicated for?

The Calcar Replacement Hip Stem is intended for use in treatment of intertrochanteric, comminuted, or femoral neck fracture; trochanteric non-union; erosion of calcar or femoral neck, and; revision total hip arthroplasty involving bone loss in the proximal femur or tumors. In addition, the Calcar Replacement Hip Stem like the predicate IOI and competitive hip stems is intended for cemented application in cases of total hip arthroplasty.

1. Patient conditions of intertrochanteric, comminuted or femoral neck fracture

2. Trochanteric nonunion

3. Erosion of the calcar or femoral neck

4. Revision total hip arthroplasty involving bone loss in the proximal femur

5. Tumors.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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 LZO

The LZO category page

  • K262473NEXUS® Hip StemMicroport Orthopedics, Inc. · 2026
  • K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
  • K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation · 2026
  • K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG · 2026
  • K260831Z1 Hip SystemZimmer, Inc. · 2026

https://510kreport.com/device/K961727 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961727: Natural-Hip System - Calcar Replacement Hip Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961727

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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