510(k) Report

510(k) · Cleared

Cleared

BI-Angular Shoulder System

K032895510(k) TraditionalCleared Nov 20, 200364-day reviewClass II21 CFR 888.3670

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

Biomet, Inc. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Nov 20, 2003 as substantially equivalent to K030710 (Biomet, Inc., 2003) and 1 other predicate after a 64-day review. Its family tree reaches back 4 generations to 1980. 10 later devices descend from it.

Decided
Nov 20, 2003
Review
64 days
Class
Class II
Product code
MBF
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K800494 (1980). 16 ancestors in all. 10 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 2 other ancestors2001: 1 other ancestor1999: 2 other ancestors1998: 2 other ancestors1992: 2 other ancestors1987: 1 other ancestor1995: 1 other ancestor1980: 1 other ancestor2005: 1 descendant cleared2011: 2 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2025: 2 descendants cleared2017: 1 descendant cleared2023: 1 descendant clearedK800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980K991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalledK030710 · Bio-Modular Shoulder System · Biomet, Inc. · 2003 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 9 other ancestors3 generations back: 1 other ancestor4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K030710 · Bio-Modular Shoulder System · Biomet, Inc. · 2003 · recalledK002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalledK991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 19800+5
  1. Root · 4 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
  2. 3 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
  3. 2 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
  4. 1 generation backK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
  5. This deviceK032895 BI-Angular Shoulder SystemBiomet, Inc. · 2003
  6. Descendant · cites it directly · 9 of its ownK042321 Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005
  7. Descendant · 2 generations on · 7 of its ownK111746 Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · Recalled
  8. Descendant · 3 generations on · 5 of its ownK143659 Equinoxe Mega ProsthesisExactech, Inc. · 2015
  9. Descendant · 3 generations on · 3 of its ownK153398 Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp · 2016
  10. Descendant · 3 generations on · 2 of its ownK173411 Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2005: 12011: 22015: 12016: 12017: 12018: 12023: 12025: 2
2005high 2 (2011) · low 0 (2006)2026

Most influential descendants

Showing 5 of 10 · See all
  • K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp · 2005 · cites it directly9descendants
  • K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc. · 2011 · 2 generations on7descendants
  • K143659Equinoxe Mega ProsthesisExactech, Inc. · 2015 · 3 generations on5descendants
  • K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp · 2016 · 3 generations on3descendants
  • K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp · 2018 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K800494New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc.1980—
−3K991585Bipolar Shoulder ProsthesisBiomet, Inc.1999—
−2K002998Biomet BI-Polar Shoulder SystemBiomet, Inc.20001
−1K030710Bio-Modular Shoulder SystemBiomet, Inc.20031
0 (this device)K032895BI-Angular Shoulder SystemBiomet, Inc.2003—
+1K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp2005—
+2K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.20111
+3K143659Equinoxe Mega ProsthesisExactech, Inc.2015—
+3K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp2016—
+3K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198710
199220
199420
199510
199820
199920
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201120
201510
201610
201710
201810
202310
202520
FIG. 1 — Lineage of K032895, 1980–2025Source: 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 MBF? 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 MBF device

  1. #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K030710Bio-Modular Shoulder SystemBiomet, Inc.20031
*K925613Proximal Humeral Replacement System
Summary page 1
…CFR Section 888.3690) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Bio-Modula@ Shoulder System - KO30710 Proximal Humeral Component - K925613 Device Description: The Bi-Angular43 Shoulder System is composed of a titanium alloy humeral stem with a modular humeral head wh…
Biomet, Inc.1994—

Also cleared against K030710: 19 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp20059

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 2 companies; a new generation was cleared every 2.7 years on median.
  • 3 of the 16 ancestors have a recall of any class.
  • Of its descendants, K042321 (Biomet Manufacturing Corp, 2005) has gone furthest, with 9 descendants of its own.
  • 19 other devices also cite its predicate K030710.

How does its category compare?

All MBF devices

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

FDA decisions per year · MBF

2in 2025

2007: 22008: 12009: 12012: 22013: 12014: 12017: 22018: 12019: 22020: 22021: 12022: 42023: 42024: 22025: 22026 (partial year): 1
2007high 4 (2022) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBF

144in 2023

2022: 164 days median2023: 144 days median
2007high 164 (2022) · low 144 (2023)2026

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

Recalls per year · MBF

1in 2023

2009: 12017: 12018: 12019: 22022: 82023: 1
2007high 8 (2022) · low 0 (2007)2026

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

Adverse event reports per year · MBF

255in 2025

2007: 22008: 72009: 162010: 242011: 322012: 302013: 402014: 282015: 492016: 852017: 1932018: 992019: 472020: 242021: 362022: 1142023: 1432024: 1642025: 255
2007high 255 (2025) · low 2 (2007)2025

MAUDE reports naming product code MBF, 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
20072—02
20081—07
20091—116
20100—024
20110—032
20122—030
20131—040
20141—028
20150—049
20160—085
20172—1193
20181—199
20192—247
20202—024
20211—036
202241648114
202341441143
20242—0164
20252—0255
20261—0—

What is it indicated for?

1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis

2) Rheumatoid arthritis

3) Revision where other devices or treatments have failed

4) Correction of functional deformity

5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate

6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Non-coated (InterlokQ) devices and all polyethylene components are indicated for cemented application only.

Indications for use as stated in the FDA summary.

Also cleared against K030710

19 other devices cite the same predicate.

  • K191814Alliance GlenoidZimmer, Inc. · 2019
  • K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 20171 recall
  • K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
  • K143256SMR Modular GlenoidLima Corporate S.P.A. · 2015
  • K140390Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp · 2014
  • K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 20131 recall

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 MBF

The MBF category page

  • K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive…Zimmer, Inc. · 2026
  • K251098Identity Revision Humeral StemsZimmer, Inc. · 2025
  • K250848Identity Shoulder SystemZimmer, Inc. · 2025
  • K240876Identity Shoulder SystemZimmer, Inc. · 2024
  • K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024

https://510kreport.com/device/K032895 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032895: BI-Angular Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032895

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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