510(k) Report

510(k) · Cleared

Cleared

IM Total Femur

K033871510(k) TraditionalCleared Apr 16, 2004126-day reviewClass II21 CFR 888.3350

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

Biomet, Inc. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Apr 16, 2004 as substantially equivalent to K002757 (Biomet, Inc., 2000) and 4 other predicates after a 126-day review. Its family tree reaches back 2 generations to 1981. 1 later device descends from it.

Decided
Apr 16, 2004
Review
126 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K810258 (1981). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 2 other ancestors1992: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2015: 1 descendant clearedK810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 1981K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 199819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant K974558 · Salvage/Onocology Hip and Total Femur System · Biomet, Inc. · 1998K810258 · Proximal Fermoral Hip Replacement · Biomet, Inc. · 19810
  1. Root · 2 generations backK810258 Proximal Fermoral Hip ReplacementBiomet, Inc. · 1981
  2. 1 generation backK974558 Salvage/Onocology Hip and Total Femur SystemBiomet, Inc. · 1998
  3. This deviceK033871 IM Total FemurBiomet, Inc. · 2004
  4. Descendant · cites it directly · 0 of its ownK152621 OSS/Arcos IM Total Femur RodBiomet, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K152621OSS/Arcos IM Total Femur RodBiomet, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K810258Proximal Fermoral Hip ReplacementBiomet, Inc.1981—
−1K974558Salvage/Onocology Hip and Total Femur SystemBiomet, Inc.1998—
0 (this device)K033871IM Total FemurBiomet, Inc.2004—
+1K152621OSS/Arcos IM Total Femur RodBiomet, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199410
199510
200020
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K033871, 1981–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 JDI? 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 JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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? (5)

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
*K002757Oncology Salvage System
Summary page 1
…mi-constrained, Polymer/Metal/Polymer, cemented (21 CFR Part 888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Oncology Salvage System (K002757), Salvage/Oncology Hip and Total Femur System (K974558), Maxim®0 (MCK) Total Knee System (K915132), Biomet SCK Knee System (K0032…
Biomet, Inc.200014
*K974558Salvage/Onocology Hip and Total Femur System
Summary page 1
…CFR Part 888.3560) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Oncology Salvage System (K002757), Salvage/Oncology Hip and Total Femur System (K974558), Maxim®0 (MCK) Total Knee System (K915132), Biomet SCK Knee System (K003296), AVL Hinged Knee (K010774). Device Description: T…
Biomet, Inc.1998—
*K915132MCK Maximum Congruent Knee) Knee System
Summary page 1
…s To Which Substantial Equivalence Is Claimed: Oncology Salvage System (K002757), Salvage/Oncology Hip and Total Femur System (K974558), Maxim®0 (MCK) Total Knee System (K915132), Biomet SCK Knee System (K003296), AVL Hinged Knee (K010774). Device Description: The IM Total Femur is, in simplest terms, an…
Biomet, Inc.19926
*K003296Biomet SCK Knee System
Summary page 1
…Is Claimed: Oncology Salvage System (K002757), Salvage/Oncology Hip and Total Femur System (K974558), Maxim®0 (MCK) Total Knee System (K915132), Biomet SCK Knee System (K003296), AVL Hinged Knee (K010774). Device Description: The IM Total Femur is, in simplest terms, an intramedullary (IM) rod which co…
Biomet, Inc.2000—
*K010774Avl Hinge Knee System
Summary page 1
…ge System (K002757), Salvage/Oncology Hip and Total Femur System (K974558), Maxim®0 (MCK) Total Knee System (K915132), Biomet SCK Knee System (K003296), AVL Hinged Knee (K010774). Device Description: The IM Total Femur is, in simplest terms, an intramedullary (IM) rod which connects a proximal hip repla…
Biomet, Inc.2001—

Also cleared against K002757: 20 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K152621OSS/Arcos IM Total Femur RodBiomet, Inc.20150

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 23 years and passes through 1 company; a new generation was cleared every 17.0 years on median.
  • 3 of the 8 ancestors have a recall of any class.
  • Of its descendants, K152621 (Biomet, Inc., 2015) has gone furthest, with 0 descendants of its own.
  • 20 other devices also cite its predicate K002757.

How does its category compare?

All JDI devices

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

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

What is it indicated for?

Total hip and knee joint replacement in cases of:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis

2. Correction of varus, valgus or post traumatic deformity

3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement

4. Ligament deficiencies

5. Tumor resections

6. Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques

7. Revision of previously failed total joint replacement

8. Trauma

Indications for use as stated in the FDA summary.

Also cleared against K002757

20 other devices cite the same predicate.

  • K190100USTAR II SystemUnited Orthopedic Corporation · 20195 recalls
  • K141331Biomet Orthopaedic Salvage System (Oss)Biomet, Inc. · 2014
  • K123501Oss Modular Stems, Oss Diaphyseal SegmentsBiomet, Inc. · 2013
  • K121056Mets Modular Proximal FemurStanmore Implants Worldwide, Ltd. · 2012
  • K121055Mets Modular Total FemurStanmore Implants Worldwide, Ltd. · 2012
  • K121029Mets Modular Distal FemurStanmore Implants Worldwide, Ltd. · 2012

More from Biomet, Inc.

449 FDA decisions under this applicant name. See the company

  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K251270Taperloc® Complete Hip StemBiomet, Inc. · 2026
  • K241014Biomet Kirschner Wires (K-Wires)Biomet, Inc. · 2024
  • K222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc. · 2022
  • K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc. · 2022

Recent decisions in JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
  • K253434OSSTM Orthopedic Salvage SystemBiomet, Inc. · 2026
  • K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer Biomet · 2025
  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K033871 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033871: IM Total Femur.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033871

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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