510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Bio-Modular Shoulder System

K030710510(k) TraditionalCleared Jun 4, 200390-day reviewClass II21 CFR 888.3650Recalls 1

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

Biomet, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Cleared on Jun 4, 2003 as substantially equivalent to K872454 (Biomet, Inc., 1987) and 9 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1980. 1 of the 268 devices in its family, counting itself, has a Class I recall. 253 later devices descend from it. It has been recalled once.

Decided
Jun 4, 2003
Review
90 days
Class
Class II
Product code
KWT
Recalls
1
Predicates
10

Its longest line of descent runs back 3 generations to K800494 (1980). 14 ancestors in all. 253 later devices descend from it, 20 citing it directly. 1 of the 268 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1999: 2 other ancestors1998: 2 other ancestors1994: 1 other ancestor1992: 2 other ancestors1987: 1 other ancestor1995: 1 other ancestor1980: 1 other ancestor2013: 9 descendants cleared2017: 13 descendants cleared2007: 4 descendants cleared2014: 9 descendants cleared2019: 18 descendants cleared2003: 1 descendant cleared2011: 9 descendants cleared2005: 3 descendants cleared2004: 1 descendant cleared2006: 4 descendants cleared2015: 6 descendants cleared2012: 12 descendants cleared2008: 2 descendants cleared, 1 with a Class I recall12020: 18 descendants cleared2021: 24 descendants cleared2018: 15 descendants cleared2022: 20 descendants cleared2025: 19 descendants cleared2010: 5 descendants cleared2009: 1 descendant cleared2016: 10 descendants cleared2023: 17 descendants cleared2024: 14 descendants cleared2026: 19 descendants clearedK800494 · New Jersey Hemiarthroplasty Sholder Pros · Depuy, Inc. · 1980K991585 · Bipolar Shoulder Prosthesis · Biomet, Inc. · 1999K002998 · Biomet BI-Polar Shoulder System · Biomet, Inc. · 2000 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 20 descendants2 generations forward: 48 descendants, 1 with a Class I recall13 generations forward: 72 descendants4 generations forward: 52 descendants5 generations forward: 28 descendants6 generations forward: 20 descendants7 generations forward: 10 descendants8 generations forward: 3 descendants K002998 · 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 · 3 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
  2. 2 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
  3. 1 generation backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
  4. This deviceK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003
  5. Descendant · cites it directly · 176 of its ownK043100 Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid…Biomet, Inc. · 2005 · Recalled
  6. Descendant · cites it directly · 175 of its ownK072804 Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007
  7. Descendant · 2 generations on · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  8. Descendant · cites it directly · 138 of its ownK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled
  9. Descendant · cites it directly · 120 of its ownK071147 Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007

Showing 5 of 253 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12005: 32006: 42007: 42008: 22009: 12010: 52011: 92012: 122013: 92014: 92015: 62016: 102017: 132018: 152019: 182020: 182021: 242022: 202023: 172024: 142025: 192026: 19
2003high 24 (2021) · low 1 (2003)2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder2 generations on · 2008

Most influential descendants

Showing 5 of 253 · See all
  • K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc. · 2005 · cites it directly176descendants
  • K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007 · cites it directly175descendants
  • K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 2 generations on172descendants
  • K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · cites it directly138descendants
  • K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007 · cites it directly120descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K800494New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc.1980—
−2K991585Bipolar Shoulder ProsthesisBiomet, Inc.1999—
−1K002998Biomet BI-Polar Shoulder SystemBiomet, Inc.20001
0 (this device)K030710Bio-Modular Shoulder SystemBiomet, Inc.2003—
+1K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc.20051
+1K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007—
+2K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
+1K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20066
+1K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198710
199220
199410
199510
199820
199920
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200530
200640
200740
200821
200910
201050
201190
2012120
201390
201490
201560
2016100
2017130
2018150
2019180
2020180
2021240
2022200
2023170
2024140
2025190
2026190
FIG. 1 — Lineage of K030710, 1980–2026Source: 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.

1 device in this family has a Class I recall. 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 KWT device

  1. #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 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? (10)

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
*K872454Biomet Modular Shoulder Prosthesis
Summary page 1
…or Uncemented (21 CFR Section 888.3690) Legally Marketed Devfce to which Substantial Equivalence is claimed: The Bio-Modular43 Shoulder System cleared by 510(k)s K872454, K915596, K992119, K992899 and K002998. The Gobam Advantage Shoulder System cleared by 510(k)s K914695, K943300, K974044,K…
Biomet, Inc.1987—
*K915596Biomodular Shoulder Humeral Head W/ Ionguard
Summary page 1
…ented (21 CFR Section 888.3690) Legally Marketed Devfce to which Substantial Equivalence is claimed: The Bio-Modular43 Shoulder System cleared by 510(k)s K872454, K915596, K992119, K992899 and K002998. The Gobam Advantage Shoulder System cleared by 510(k)s K914695, K943300, K974044,K981487 an…
Biomet, Inc.1992—
*K992119Bio-Modular Shoulder System
Summary page 1
…CFR Section 888.3690) Legally Marketed Devfce to which Substantial Equivalence is claimed: The Bio-Modular43 Shoulder System cleared by 510(k)s K872454, K915596, K992119, K992899 and K002998. The Gobam Advantage Shoulder System cleared by 510(k)s K914695, K943300, K974044,K981487 and KO11047.…
Biomet, Inc.19991
*K992899Bio-Modular Shoulder Offset Humeral Heads
Summary page 1
…ion 888.3690) Legally Marketed Devfce to which Substantial Equivalence is claimed: The Bio-Modular43 Shoulder System cleared by 510(k)s K872454, K915596, K992119, K992899 and K002998. The Gobam Advantage Shoulder System cleared by 510(k)s K914695, K943300, K974044,K981487 and KO11047. Device D…
Biomet, Inc.1999—
*K002998Biomet BI-Polar Shoulder System
Summary page 1
…) Legally Marketed Devfce to which Substantial Equivalence is claimed: The Bio-Modular43 Shoulder System cleared by 510(k)s K872454, K915596, K992119, K992899 and K002998. The Gobam Advantage Shoulder System cleared by 510(k)s K914695, K943300, K974044,K981487 and KO11047. Device Description:…
Biomet, Inc.20001
*K914695Global Total Shoulder
Summary page 1
…imed: The Bio-Modular43 Shoulder System cleared by 510(k)s K872454, K915596, K992119, K992899 and K002998. The Gobam Advantage Shoulder System cleared by 510(k)s K914695, K943300, K974044,K981487 and KO11047. Device Description: The Bio-Modular@Shoulder System consists of a humeral stern that i…
Depuy, Inc.1992—
*K943300Depuy Porous Coated Global Shoulder
Summary page 1
…e Bio-Modular43 Shoulder System cleared by 510(k)s K872454, K915596, K992119, K992899 and K002998. The Gobam Advantage Shoulder System cleared by 510(k)s K914695, K943300, K974044,K981487 and KO11047. Device Description: The Bio-Modular@Shoulder System consists of a humeral stern that is used in c…
Depuy, Inc.1994—
*K974044Global Total Shoulder Eccentric Humeral Head
Summary page 1
…ular43 Shoulder System cleared by 510(k)s K872454, K915596, K992119, K992899 and K002998. The Gobam Advantage Shoulder System cleared by 510(k)s K914695, K943300, K974044,K981487 and KO11047. Device Description: The Bio-Modular@Shoulder System consists of a humeral stern that is used in conjunctio…
DePuy Orthopaedics, Inc.1998—
*K981487Depuy Global Shoulder Glenoid
Summary page 1
…houlder System cleared by 510(k)s K872454, K915596, K992119, K992899 and K002998. The Gobam Advantage Shoulder System cleared by 510(k)s K914695, K943300, K974044,K981487 and KO11047. Device Description: The Bio-Modular@Shoulder System consists of a humeral stern that is used in conjunction with a…
DePuy Orthopaedics, Inc.1998—
*K011047Global Advantage Humeral Stem with PorocoatDePuy Orthopaedics, Inc.2001—

Also cleared against K872454: 3 other devices →

What descends from it? (253)

See all 253

20 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc.2005176
K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175
K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp2006138
K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120
K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360
K060694Modular Hybrid GlenoidBiomet Manufacturing Corp200657
K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231
K070565Cofield Total Shoulder SystemSmith & Nephew, Inc.200726
K040610Versa-Dial Humeral HeadBiomet Manufacturing, Inc.200417
K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.201712

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 1, 2012Class IIZ-0474-2013Process controlThe items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially…

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 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.
  • 2 of the 14 ancestors have a recall of any class.
  • Of its descendants, K043100 (Biomet, Inc., 2005) has gone furthest, with 176 descendants of its own.
  • 3 other devices also cite its predicate K872454.

How does its category compare?

All KWT devices

KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWT

4in 2025

2007: 12010: 12011: 52012: 12013: 12014: 12015: 22016: 22017: 12018: 22019: 42020: 12021: 12022: 12023: 12024: 12025: 42026 (partial year): 1
2007high 5 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWT

242in 2025

2011: 165 days median2019: 91 days median2025: 242 days median
2007high 242 (2025) · low 91 (2019)2026

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

Recalls per year · KWT

1in 2023

2008: 12010: 72012: 22013: 12016: 12017: 12018: 12019: 32023: 1
2007high 7 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWT

749in 2025

2007: 322008: 482009: 582010: 712011: 1122012: 832013: 1132014: 1682015: 1762016: 4452017: 5602018: 4802019: 4192020: 2152021: 2282022: 2732023: 3612024: 6012025: 749
2007high 749 (2025) · low 32 (2007)2025

MAUDE reports naming product code KWT, 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
20071—032
20080—148
20090—058
20101—771
201151650112
20121—283
20131—1113
20141—0168
20152—0176
20162—1445
20171—1560
20182—1480
20194913419
20201—0215
20211—0228
20221—0273
20231—1361
20241—0601
202542420749
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. Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

Indications for use as stated in the FDA summary.

Also cleared against K872454

3 other devices cite the same predicate.

  • K992899Bio-Modular Shoulder Offset Humeral HeadsBiomet, Inc. · 1999
  • K980244Aequalis Shoulder ProsthesisTornier · 1999
  • K961571Cocr BI-Angular Humeral ComponentBiomet, Inc. · 1996

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 KWT

The KWT category page

  • K262173N22 Offset Humeral HeadShoulder Innovations, Inc. · 2026
  • K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc. · 2025
  • K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc. · 20251 recall
  • K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2025
  • K241817InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025

https://510kreport.com/device/K030710 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030710: Bio-Modular Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030710

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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