510(k) Report

510(k) · Cleared

Cleared

Biomet Sports Medicine Sternal Closure System

K110039510(k) TraditionalCleared May 3, 2011117-day reviewClass II21 CFR 888.3010

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

Biomet Sports Medicine · JDQ Cerclage, Fixation

Cleared on May 3, 2011 as substantially equivalent to K931271 (ETHICON, Inc., 1994) and 5 other predicates after a 117-day review. Its family tree reaches back 8 generations to 1976. 1 later device descends from it.

Decided
May 3, 2011
Review
117 days
Class
Class II
Product code
JDQ
Recalls
None
Predicates
6

Its longest line of descent runs back 8 generations to K761228 (1976). 25 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors1995: 1 other ancestor1994: 3 other ancestors1993: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors1996: 3 other ancestors1991: 1 other ancestor1988: 1 other ancestor1986: 2 other ancestors2020: 1 descendant 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. · 200619801990200020102020
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: 1 descendant K063506 · 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
  1. Root · 8 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 7 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. 6 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  4. 5 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
  5. 4 generations backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
  6. 3 generations backK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
  7. 2 generations backK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
  8. 1 generation backK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
  9. This deviceK110039 Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine · 2011
  10. Descendant · cites it directly · 0 of its ownK191030 Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™…Life Technologies Corporation · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K761228Luhr Mandibular Compression-Screw SystemHowmedica Corp.1976—
−7K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997—
−6K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997—
−5K974785Auto-Drive Bone ScrewOsteomed Corp.1998—
−4K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc.2002—
−3K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc.2003—
−2K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2003—
−1K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc.2006—
0 (this device)K110039Biomet Sports Medicine Sternal Closure SystemBiomet Sports Medicine2011—
+1K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx…Life Technologies Corporation2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198810
199110
199310
199430
199510
199630
199720
199810
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K110039, 1976–2020Source: 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 JDQ? 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 JDQ device

  1. #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 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? (6)

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
*K931271Ethi-Pack* Surgical Stainless Steel Suture
Summary page 1
…Closure System Classification Name: Cerclage, Fixation (21CFR §888.3010) JDQ Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K93 1271 and K946173 Ethi-Pack Surgical Stainless Steel Suture K930015 and K013059 Stony Brook Sterna-wire / Sterna-Band TM…
ETHICON, Inc.1994—
*K946173Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…
Summary page 1
…em Classification Name: Cerclage, Fixation (21CFR §888.3010) JDQ Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K93 1271 and K946173 Ethi-Pack Surgical Stainless Steel Suture K930015 and K013059 Stony Brook Sterna-wire / Sterna-Band TM K011076 a…
ETHICON, Inc.199510
*K930015Sternal Band
Summary page 1
…(21CFR §888.3010) JDQ Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K93 1271 and K946173 Ethi-Pack Surgical Stainless Steel Suture K930015 and K013059 Stony Brook Sterna-wire / Sterna-Band TM K011076 and K063506 SternaLockT " Rigid Sternal System / Lorenz…
Stony Brook Surgical Innovations, Inc.1993—
*K013059Stony Brook Surgical Innovaions Sterna-Wire (Sternal Sutures)
Summary page 1
…3010) JDQ Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K93 1271 and K946173 Ethi-Pack Surgical Stainless Steel Suture K930015 and K013059 Stony Brook Sterna-wire / Sterna-Band TM K011076 and K063506 SternaLockT " Rigid Sternal System / Lorenz Sternal…
Stony Brook Surgical Innovations, Inc.2001—
*K011076Lorenz Sternal Closure System with Modular Screw
Summary page 1
…quivalence Is Claimed: K93 1271 and K946173 Ethi-Pack Surgical Stainless Steel Suture K930015 and K013059 Stony Brook Sterna-wire / Sterna-Band TM K011076 and K063506 SternaLockT " Rigid Sternal System / Lorenz Sternal Closure System Device Descriptio…
Walter Lorenz Surgical, Inc.2001—
*K063506Lorenz Sternal Closure System
Summary page 1
…s Claimed: K93 1271 and K946173 Ethi-Pack Surgical Stainless Steel Suture K930015 and K013059 Stony Brook Sterna-wire / Sterna-Band TM K011076 and K063506 SternaLockT " Rigid Sternal System / Lorenz Sternal Closure System Device Description: The Biome…
Walter Lorenz Surgical, Inc.2006—

Also cleared against K931271: 18 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
K191030Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic…Life Technologies Corporation20200

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 3.0 years on median.
  • 2 of the 25 ancestors have a recall of any class.
  • Of its descendants, K191030 (Life Technologies Corporation, 2020) has gone furthest, with 0 descendants of its own.
  • 18 other devices also cite its predicate K931271.

How does its category compare?

All JDQ devices

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

FDA decisions per year · JDQ

2in 2025

2007: 12008: 22009: 22011: 62012: 32013: 12014: 22015: 52016: 42017: 12018: 62020: 42022: 22023: 32024: 32025: 22026 (partial year): 1
2007high 6 (2011) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDQ

130in 2024

2011: 130 days median2012: 134 days median2015: 92 days median2016: 129 days median2018: 101 days median2020: 93 days median2023: 141 days median2024: 130 days median
2007high 141 (2023) · low 92 (2015)2026

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

Recalls per year · JDQ

5in 2019

2008: 22010: 22013: 12015: 12019: 5
2007high 5 (2019) · low 0 (2007)2026

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

Adverse event reports per year · JDQ

84in 2025

2007: 52008: 252009: 192010: 282011: 302012: 1302013: 3212014: 2232015: 2052016: 2242017: 1382018: 1822019: 1582020: 1252021: 1412022: 1342023: 982024: 1152025: 84
2007high 321 (2013) · low 5 (2007)2025

MAUDE reports naming product code JDQ, 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—05
20082—225
20092—019
20100—228
20116130030
201231340130
20131—1321
20142—0223
20155921205
201641290224
20171—0138
201861010182
20190—5158
20204930125
20210—0141
20222—0134
20233141098
202431300115
20252—084
20261—0—

What is it indicated for?

The Biomet Sports Medicine 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.

Indications for use as stated in the FDA summary.

Also cleared against K931271

18 other devices cite the same predicate.

  • K173579Thorecon™ Fixation SystemA & E Medical Corporation · 2018
  • K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
  • K142484Sternal Closure SystemJace Medical, LLC · 2014
  • K141007Demesteel (Stainless Steel) Non-Absorbable SutureDemetech Corp. · 2014
  • K120016Pioneer Sternal Assist Implant SystemPioneer Surgical Technology, Inc. · 2012
  • K120177Spinal Elements Cerclage SystemSpinal Elements, Inc. · 2012

More from Biomet Sports Medicine

9 FDA decisions under this applicant name. See the company

  • K140908Juggerknot Mini Soft AnchorBiomet Sports Medicine · 2014
  • K122437NO-Profile Screws NO-Profile Washer NO-Profile Screws Washerloc WashersBiomet Sports Medicine · 2013
  • K123485Juggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors with Needles…Biomet Sports Medicine · 20132 recalls
  • K110879Biomet Sports Medicine Juggerknot (TM) Mini Soft AnchorBiomet Sports Medicine · 20112 recalls
  • K111564Maxfire Marxmen Meniscal Repair DeviceBiomet Sports Medicine · 2011

Recent decisions in JDQ

The JDQ category page

  • K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
  • K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda. · 2025
  • K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc. · 2025
  • K232733Mbrace CableMedacta International S.A. · 2024
  • K233949ACCORD Cable SystemSmith & Nephew, Inc. · 2024

https://510kreport.com/device/K110039 · printed Nov 4, 2026

Cite this page

510(k) Report. “K110039: Biomet Sports Medicine Sternal Closure System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110039

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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