510(k) Report

510(k) · Cleared

Cleared

Biomet Microfixation Sternal Closure System

K111908510(k) TraditionalCleared Nov 29, 2011147-day reviewClass II21 CFR 888.3040

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

Biomet Microfixation, Inc. · HWC Screw, Fixation, Bone

Cleared on Nov 29, 2011 as substantially equivalent to K011076 (Walter Lorenz Surgical, Inc., 2001) and 7 other predicates after a 147-day review. Its family tree reaches back 9 generations to 1976. 78 later devices descend from it.

Decided
Nov 29, 2011
Review
147 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
8

Its longest line of descent runs back 9 generations to K761228 (1976). 26 ancestors in all. 78 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestor1994: 3 other ancestors1998: 1 other ancestor1997: 2 other ancestors1996: 3 other ancestors1991: 1 other ancestor1988: 1 other ancestor1986: 2 other ancestors2012: 1 descendant cleared2018: 4 descendants cleared2025: 15 descendants cleared2014: 1 descendant cleared2022: 7 descendants cleared2019: 3 descendants cleared2021: 3 descendants cleared2015: 3 descendants cleared2016: 5 descendants cleared2024: 15 descendants cleared2023: 8 descendants cleared2026: 13 descendants clearedK761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997×2: 2 generations cleared close together, K970912 (1997), K974785 (1998) K013954 · Lorenz Self Drilling Screws · Walter Lorenz Surgical, Inc. · 2002×2: 2 generations cleared close together, K032228 (2003), K033740 (2003) K063506 · Lorenz Sternal Closure System · Walter Lorenz Surgical, Inc. · 2006K110574 · Biomet Microfixation Sternalock Blu Sternal Closure System · Biomet Microfixation, Inc. · 2011 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors3 generations back: 2 other ancestors4 generations back: 2 other ancestors5 generations back: 2 other ancestors6 generations back: 6 other ancestors 1 generation forward: 6 descendants2 generations forward: 7 descendants3 generations forward: 12 descendants4 generations forward: 10 descendants5 generations forward: 19 descendants6 generations forward: 22 descendants7 generations forward: 2 descendants K110574 · Biomet Microfixation Sternalock Blu Sternal Closure System · Biomet Microfixation, Inc. · 2011 · recalledK063506 · Lorenz Sternal Closure System · Walter Lorenz Surgical, Inc. · 2006K033740 · Lorenz Sternal Closure System · Walter Lorenz Surgical, Inc. · 2003K032228 · Lorenz 2.4 Self Drilling Screws · Walter Lorenz Surgical, Inc. · 2003K013954 · Lorenz Self Drilling Screws · Walter Lorenz Surgical, Inc. · 2002K974785 · Auto-Drive Bone Screw · Osteomed Corp. · 1998K970912 · Leibinger Self-Drilling Screw · Howmedica Leibinger, Inc. · 1997K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997K761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976−50+5
  1. Root · 9 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 5 generations between
  3. 3 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
  4. 2 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
  5. 1 generation backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
  6. This deviceK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011
  7. Descendant · cites it directly · 75 of its ownK121302 Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
  8. Descendant · 2 generations on · 43 of its ownK151019 SternaLock® 360 Sternal Closure SystemBiomet Microfixation · 2015
  9. Descendant · 3 generations on · 40 of its ownK163007 Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation · 2016
  10. Descendant · 2 generations on · 39 of its ownK202889 Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021
  11. Descendant · 3 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
Show all 9 generations
  1. Root · 9 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 8 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. 7 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  4. 6 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
  5. 5 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
  6. 4 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
  7. 3 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
  8. 2 generations backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
  9. 1 generation backK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
  10. This deviceK111908 Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc. · 2011

Showing 5 of 78 descendants. See all descendants

Descendants cleared per year

2012: 12014: 12015: 32016: 52018: 42019: 32021: 32022: 72023: 82024: 152025: 152026: 13
2012high 15 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 78 · See all
  • K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012 · cites it directly75descendants
  • K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation · 2015 · 2 generations on43descendants
  • K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation · 2016 · 3 generations on40descendants
  • K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · 2021 · 2 generations on39descendants
  • K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 3 generations on36descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K761228Luhr Mandibular Compression-Screw SystemHowmedica Corp.1976—
−8K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997—
−7K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997—
−6K974785Auto-Drive Bone ScrewOsteomed Corp.1998—
−5K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002—
−4K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003—
−3K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003—
−2K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2006—
−1K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc.20111
0 (this device)K111908Biomet Microfixation Sternal Closure SystemBiomet Microfixation, Inc.2011—
+1K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation2012—
+2K151019SternaLock® 360 Sternal Closure SystemBiomet Microfixation2015—
+3K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation2016—
+2K202889Able Medical Devices Valkyrie Thoracic Fixation SystemJm Longyear Manufacturing, LLC D.B.A. Able Medical Devices2021—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198810
199110
199430
199510
199630
199720
199810
200110
201010
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201410
201530
201650
201840
201930
202130
202270
202380
2024150
2025150
2026130
FIG. 1 — Lineage of K111908, 1976–2026Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.3 · 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? (8)

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
*K011076Lorenz Sternal Closure System with Modular Screw
Summary page 2
…ial Equivalence: Biomet Microfixation considers the Biomet Micrafixation Sternal Closure System to be equivalent to the Lorenz Sternal Closure System with Modular Screw (K011076), the Lorenz Sternal Closure System (K033740), the Lorenz Sternal Closure System (K063506) and the Biamet Microfixation Sternal C…
Walter Lorenz Surgical, Inc.2001—
*K033740Lorenz Sternal Closure System
Summary page 2
…rs the Biomet Micrafixation Sternal Closure System to be equivalent to the Lorenz Sternal Closure System with Modular Screw (K011076), the Lorenz Sternal Closure System (K033740), the Lorenz Sternal Closure System (K063506) and the Biamet Microfixation Sternal Closure System (K110574) as well as Synthes St…
Walter Lorenz Surgical, Inc.2003—
*K063506Lorenz Sternal Closure System
Summary page 2
…ystem to be equivalent to the Lorenz Sternal Closure System with Modular Screw (K011076), the Lorenz Sternal Closure System (K033740), the Lorenz Sternal Closure System (K063506) and the Biamet Microfixation Sternal Closure System (K110574) as well as Synthes Sternal Closure System (K093772), Synthes Zipfi…
Walter Lorenz Surgical, Inc.2006—
*K110574Biomet Microfixation Sternalock Blu Sternal Closure System
Summary page 2
…th Modular Screw (K011076), the Lorenz Sternal Closure System (K033740), the Lorenz Sternal Closure System (K063506) and the Biamet Microfixation Sternal Closure System (K110574) as well as Synthes Sternal Closure System (K093772), Synthes Zipfix (K(110789), and Ethicon K(931271 and K(946173 Stainless Stee…
Biomet Microfixation, Inc.20111
*K093772Synthes Sternal Fixation System
Summary page 2
…re System (K033740), the Lorenz Sternal Closure System (K063506) and the Biamet Microfixation Sternal Closure System (K110574) as well as Synthes Sternal Closure System (K093772), Synthes Zipfix (K(110789), and Ethicon K(931271 and K(946173 Stainless Steel Suture Wire. - ''…
Synthes2010—
*K110789Synthes Sternal Zipfix System
Cleared while this submission was under review
Summary page 2
…des the same plate and screws plates and screws Design screw configurations Identical K110789 (PEEK Optima LT-3) contained in the predicate cable ties with detachable…
Synthes (Usa)20113
*K931271Ethi-Pack* Surgical Stainless Steel Suture
Summary page 2
…tem (K063506) and the Biamet Microfixation Sternal Closure System (K110574) as well as Synthes Sternal Closure System (K093772), Synthes Zipfix (K(110789), and Ethicon K(931271 and K(946173 Stainless Steel Suture Wire. - '' * . PrediatstI0I7;…
ETHICON, Inc.1994—
*K946173Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…
Summary page 2
…and the Biamet Microfixation Sternal Closure System (K110574) as well as Synthes Sternal Closure System (K093772), Synthes Zipfix (K(110789), and Ethicon K(931271 and K(946173 Stainless Steel Suture Wire. - '' * . PrediatstI0I7;…
ETHICON, Inc.199510

Also cleared against K011076: 8 other devices →

What descends from it? (78)

See all 78

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

NumberDeviceApplicantDecidedDescendants
K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation201275
K202914SternaFuse Fixation SystemFusion Innovations, LLC20221
K173579Thorecon™ Fixation SystemA & E Medical Corporation20181
K142484Sternal Closure SystemJace Medical, LLC20141
K252661SternaFuse Ti Fixation SystemFusion Innovations, LLC20250
K181806ARIX Sternal SystemJeil Medical Corporation20180

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 35 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
  • 4 of the 26 ancestors have a recall of any class.
  • Of its descendants, K121302 (Biomet Microfixation, 2012) has gone furthest, with 75 descendants of its own.
  • 8 other devices also cite its predicate K011076.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor hone quality.

Indications for use as stated in the FDA summary.

Also cleared against K011076

8 other devices cite the same predicate.

  • K122293Pioneer Sternal Cable Plate SystemPioneer Surgical Technology, Inc. · 2012
  • K121302Biomet Microfixation Sternal Closure SystemBiomet Microfixation · 2012
  • K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine · 2011
  • K101170Acute Innovations Sternal Fixation SystemAcute Innovations, LLC · 2010
  • K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
  • K053624Medicon Stern-a-Fix Sternal Closure SystemMedicon EG · 2006

More from Biomet Microfixation, Inc.

17 FDA decisions under this applicant name. See the company

  • P020016/S010Total Temporomandibular Joint Replacement SystemBiomet Microfixation, Inc. · 2026
  • P020016/S013Total Temporomandibular Joint Replacement SystemBiomet Microfixation, Inc. · 2026
  • P020016/S011Total Temporomandibular Joint Replacement SystemBiomet Microfixation, Inc. · 2019
  • P020016/S008Total Temporomandibular Joint (TMJ) Replacement SystemBiomet Microfixation, Inc. · 2017
  • P020016/S007Total Temporomandibular Joint Replacement SystemBiomet Microfixation, Inc. · 2014

Recent decisions in HWC

The HWC category page

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  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K111908 · printed Nov 3, 2026

Cite this page

510(k) Report. “K111908: Biomet Microfixation Sternal Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K111908

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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