510(k) Report

510(k) · Cleared

Cleared

Kirschner Sholders with Titanium Plasma Spray

K961260510(k) TraditionalCleared Apr 2, 1997365-day reviewClass II21 CFR 888.3690

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

Biomet, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Apr 2, 1997 as substantially equivalent to K873073 (Kirschner Medical Corp., 1987) and 3 other predicates after a 365-day review. Its family tree reaches back 1 generation to 1987. 176 later devices descend from it.

Decided
Apr 2, 1997
Review
365 days
Class
Class II
Product code
HSD
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K873073 (1987). 4 ancestors in all. 176 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1988: 1 other ancestor1987: 1 other ancestor2006: 2 descendants cleared2002: 1 descendant cleared2000: 1 descendant cleared2010: 3 descendants cleared2004: 2 descendants cleared2014: 9 descendants cleared2013: 10 descendants cleared2019: 13 descendants cleared2020: 10 descendants cleared2021: 15 descendants cleared2018: 8 descendants cleared2022: 17 descendants cleared2017: 8 descendants cleared2025: 15 descendants cleared2011: 8 descendants cleared2012: 4 descendants cleared2016: 5 descendants cleared2015: 5 descendants cleared2026: 15 descendants cleared2023: 14 descendants cleared2024: 11 descendants clearedK873073 · Kirschner Neer-Iii Proximal Humerus · Kirschner Medical Corp. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 3 descendants2 generations forward: 22 descendants3 generations forward: 41 descendants4 generations forward: 33 descendants5 generations forward: 30 descendants6 generations forward: 33 descendants7 generations forward: 11 descendants8 generations forward: 3 descendants K873073 · Kirschner Neer-Iii Proximal Humerus · Kirschner Medical Corp. · 19870+5
  1. Root · 1 generation backK873073 Kirschner Neer-Iii Proximal HumerusKirschner Medical Corp. · 1987
  2. This deviceK961260 Kirschner Sholders with Titanium Plasma SprayBiomet, Inc. · 1997
  3. Descendant · cites it directly · 146 of its ownK023063 Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc. · 2002 · Recalled
  4. Descendant · cites it directly · 138 of its ownK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled
  5. Descendant · 2 generations on · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
  6. Descendant · 3 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  7. Descendant · 2 generations on · 98 of its ownK120794 Ascend Shoulder SystemTornier, Inc. · 2012

Showing 5 of 176 descendants. See all descendants

Descendants cleared per year

2000: 12002: 12004: 22006: 22010: 32011: 82012: 42013: 102014: 92015: 52016: 52017: 82018: 82019: 132020: 102021: 152022: 172023: 142024: 112025: 152026: 15
2000high 17 (2022) · low 0 (2001)2026

Most influential descendants

Showing 5 of 176 · See all
  • K023063Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc. · 2002 · cites it directly146descendants
  • K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · cites it directly138descendants
  • K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · 2 generations on110descendants
  • K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on108descendants
  • K120794Ascend Shoulder SystemTornier, Inc. · 2012 · 2 generations on98descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K873073Kirschner Neer-Iii Proximal HumerusKirschner Medical Corp.1987—
0 (this device)K961260Kirschner Sholders with Titanium Plasma SprayBiomet, Inc.1997—
+1K023063Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc.20022
+1K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20066
+2K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
+2K120794Ascend Shoulder SystemTornier, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198810
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200210
200420
200620
201030
201180
201240
2013100
201490
201550
201650
201780
201880
2019130
2020100
2021150
2022170
2023140
2024110
2025150
2026150
FIG. 1 — Lineage of K961260, 1987–2026Source: 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.

Planning a device in HSD? 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 HSD device

  1. #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 16 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
*K873073Kirschner Neer-Iii Proximal Humerus
Summary page 2
…sma Spray are equivalent to almost all hip components on the market. Devices are identical to the following predicate Kirschner products: Kirschner II-C Humeral Stems - K873073 Modular II-C Humeral Stems - K874643 Atlas-C Modular Proximal Humeral Components - K940537 Modular Glenoid Metal Backing - K87310…
Kirschner Medical Corp.1987—
*K874643Kirschner Neer-Iii Modular Proximal Humerus
Summary page 2
…l hip components on the market. Devices are identical to the following predicate Kirschner products: Kirschner II-C Humeral Stems - K873073 Modular II-C Humeral Stems - K874643 Atlas-C Modular Proximal Humeral Components - K940537 Modular Glenoid Metal Backing - K873104
Kirschner Medical Corp.1988—
*K940537Kirschner (R) Modular II-C (TM) Total Shoulder System
Summary page 2
…to the following predicate Kirschner products: Kirschner II-C Humeral Stems - K873073 Modular II-C Humeral Stems - K874643 Atlas-C Modular Proximal Humeral Components - K940537 Modular Glenoid Metal Backing - K873104
Kirschner Medical Corp.1995—
*K873104Neer-Iii Glenoid Resurfacing Prosthesis
Summary page 2
…oducts: Kirschner II-C Humeral Stems - K873073 Modular II-C Humeral Stems - K874643 Atlas-C Modular Proximal Humeral Components - K940537 Modular Glenoid Metal Backing - K873104
Kirschner Medical Corp.1987—

Also cleared against K873073: 1 other device →

What descends from it? (176)

See all 176

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

NumberDeviceApplicantDecidedDescendants
K023063Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc.2002146
K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp2006138
K992525Acumed Modular Shoulder SystemAcu Med, Inc.200076

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 4 ancestors has a recall.
  • Of its descendants, K023063 (Biomet Orthopedics, Inc., 2002) has gone furthest, with 146 descendants of its own.
  • 1 other device also cites its predicate K873073.

How does its category compare?

All HSD devices

HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSD

1in 2024

2007: 42008: 32011: 22012: 22013: 42014: 12016: 32018: 12020: 22022: 12024: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSD

145in 2016

2007: 72 days median2008: 92 days median2013: 218 days median2016: 145 days median
2007high 218 (2013) · low 72 (2007)2026

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

Recalls per year · HSD

1in 2020

2008: 22009: 22017: 32018: 12020: 1
2007high 3 (2017) · low 0 (2007)2026

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

Adverse event reports per year · HSD

757in 2025

2007: 1282008: 2592009: 1562010: 2252011: 2412012: 2542013: 2882014: 4342015: 5742016: 7842017: 9852018: 6492019: 8302020: 6582021: 5732022: 5082023: 5862024: 6932025: 757
2007high 985 (2017) · low 128 (2007)2025

MAUDE reports naming product code HSD, 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
20074720128
20083922259
20090—2156
20100—0225
20112—0241
20122—0254
201342180288
20141—0434
20150—0574
201631450784
20170—3985
20181—1649
20190—0830
20202—1658
20210—0573
20221—0508
20230—0586
20241—0693
20250—0757
20260—0—

What is it indicated for?

1) Relief of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenchumeral joint. 2) Irreducible 3 and 4 part fractures of the proximal humerus. 3) Non-united or mal-united chronic humeral head fractures or fracture-dislocations. 4) Avascular necrosis of the humeral head. 5) Other difficult clinical management problems, including falled reconstructive procedures, where arthrodesis of resection arthroplasty are not considered acceptable.

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

Also cleared against K873073

1 other device cites the same predicate.

  • 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 HSD

The HSD category page

  • K233260Univers Revers CA Head and AdapterArthrex, Inc. · 2024
  • K221232Univers Revers Humeral Cup ImplantArthrex, Inc. · 2022
  • K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
  • K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC · 2020
  • K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018

https://510kreport.com/device/K961260 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961260: Kirschner Sholders with Titanium Plasma Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961260

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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