510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Biomet Tibial Locking Nail System

K063570510(k) TraditionalCleared Feb 27, 200790-day reviewClass II21 CFR 888.3020Recalls 3

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

Biomet Manufacturing Corp · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Feb 27, 2007 as substantially equivalent to K982953 (Biomet, Inc., 1998) after a 90-day review. Its family tree reaches back 1 generation to 1998. 37 later devices descend from it. It has been recalled 3 times.

Decided
Feb 27, 2007
Review
90 days
Class
Class II
Product code
HSB
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K982953 (1998). 37 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2017: 4 descendants cleared2024: 2 descendants cleared2008: 1 descendant cleared2015: 2 descendants cleared2014: 2 descendants cleared2025: 5 descendants cleared2013: 2 descendants cleared2012: 2 descendants cleared2026: 5 descendants cleared2023: 3 descendants cleared2019: 4 descendants cleared2016: 1 descendant cleared2020: 3 descendants cleared2021: 1 descendant clearedK982953 · Titanium Intramedullary Nails-Various Styles · Biomet, Inc. · 1998 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 9 descendants3 generations forward: 8 descendants4 generations forward: 9 descendants5 generations forward: 3 descendants6 generations forward: 2 descendants K982953 · Titanium Intramedullary Nails-Various Styles · Biomet, Inc. · 1998 · recalled0+5
  1. Root · 1 generation backK982953 Titanium Intramedullary Nails-Various StylesBiomet, Inc. · 1998 · Recalled
  2. This deviceK063570 Biomet Tibial Locking Nail SystemBiomet Manufacturing Corp · 2007
  3. Descendant · cites it directly · 18 of its ownK081243 Biomet Phoenix Ankle Nail SystemBiomet Trauma · 2008
  4. Descendant · 2 generations on · 14 of its ownK123810 Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013
  5. Descendant · cites it directly · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
  6. Descendant · 3 generations on · 8 of its ownK182307 Small Bone Phantom® Intramedullary Nail System; TTC Phantom®…Paragon 28, Inc. · 2019
  7. Descendant · 4 generations on · 6 of its ownK192163 TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2008: 12012: 22013: 22014: 22015: 22016: 12017: 42019: 42020: 32021: 12023: 32024: 22025: 52026: 5
2008high 5 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 37 · See all
  • K081243Biomet Phoenix Ankle Nail SystemBiomet Trauma · 2008 · cites it directly18descendants
  • K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd. · 2013 · 2 generations on14descendants
  • K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · cites it directly10descendants
  • K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2019 · 3 generations on8descendants
  • K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc. · 2020 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K982953Titanium Intramedullary Nails-Various StylesBiomet, Inc.19984
0 (this device)K063570Biomet Tibial Locking Nail SystemBiomet Manufacturing Corp2007—
+1K081243Biomet Phoenix Ankle Nail SystemBiomet Trauma2008—
+2K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.2013—
+1K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral…I.T.S. GmbH2014—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary…Paragon 28, Inc.2019—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201220
201320
201420
201520
201610
201740
201940
202030
202110
202330
202420
202550
202650
FIG. 1 — Lineage of K063570, 1998–2026Source: 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 HSB? 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 HSB device

  1. #1 K200869 Gamma3 Systemscore 19.8 · 8 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? (1)

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
*K982953Titanium Intramedullary Nails-Various Styles
Summary page 1
…ories (CFR 888.3020) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Titanium Intramedullary Rods-Various (Uniflex®'Tiibial Nail (Low Profile) - K(982953 (Biomet Inc.) Device Description: The Biomnet® Tibial Locking Nail System isan intramedullary nail, designed to be inserted throu…
Biomet, Inc.19984

Also cleared against K982953: 11 other devices →

What descends from it? (37)

See all 37

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

NumberDeviceApplicantDecidedDescendants
K081243Biomet Phoenix Ankle Nail SystemBiomet Trauma200818
K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410
K150867Affixus Tibial Nailing SystemBiomet, Inc.20153
K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc.20242
K170972Apex Tibial Nailing SystemOrthoxel20171
K243907Affixus Tibial Nailing System - 4mm screwsZimmer, Inc.20250

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 25, 2020Class IIZ-0627-2021Process controlSpecific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Nov 25, 2020Class IIZ-0625-2021Process controlSpecific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Apr 1, 2016Class IIZ-1819-2016Equipment maintenanceInsufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K081243 (Biomet Trauma, 2008) has gone furthest, with 18 descendants of its own.
  • 11 other devices also cite its predicate K982953.

How does its category compare?

All HSB devices

HSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007: 82008: 112009: 182010: 142011: 162012: 172013: 182014: 192015: 222016: 82017: 232018: 172019: 132020: 172021: 102022: 122023: 112024: 132025: 152026 (partial year): 18
2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007: 68 days median2008: 57 days median2009: 86 days median2010: 117 days median2011: 78 days median2012: 112 days median2013: 105 days median2014: 147 days median2015: 111 days median2016: 124 days median2017: 119 days median2018: 134 days median2019: 132 days median2020: 112 days median2021: 94 days median2022: 172 days median2023: 162 days median2024: 195 days median2025: 106 days median2026 (partial year): 151 days median
2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

2008: 92009: 812010: 182011: 22012: 72013: 142014: 32015: 32016: 62017: 662018: 562019: 62020: 62021: 22022: 12023: 12024: 12025: 182026 (partial year): 1
2007high 81 (2009) · low 0 (2007)2026

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

Adverse event reports per year · HSB

2,911in 2025

2007: 1622008: 1842009: 3342010: 4542011: 6622012: 1,0792013: 1,7732014: 1,4742015: 1,6712016: 1,9202017: 1,4472018: 3,5262019: 2,5172020: 3,2992021: 4,1112022: 2,7332023: 2,2192024: 2,8692025: 2,911
2007high 4,111 (2021) · low 162 (2007)2025

MAUDE reports naming product code HSB, 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
20078680162
200811579184
2009188681334
20101411718454
201116782662
20121711271,079
201318105141,773
20141914731,474
20152211131,671
2016812461,920
201723119661,447
201817134563,526
20191313262,517
20201711263,299
2021109424,111
20221217212,733
20231116212,219
20241319512,869
202515106182,911
2026181511—

What is it indicated for?

The Biomet-Tibial Locking Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease, and the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity and arthrodesis.

Indications for use as stated in the FDA summary.

Also cleared against K982953

11 other devices cite the same predicate.

  • K151456Small Bone Nail ImplantVilex IN Tennessee, Inc. · 2015
  • K072161Biomet Femoral Locking Nail SystemBiomet Manufacturing Corp · 20078 recalls
  • K042409Modular Arthrodesis NailBiomet, Inc. · 20042 recalls
  • K031438Acumed Small Bone Locking Rod System IIAcumed, LLC · 20031 recall
  • K023115Ace VersanailDePuy Orthopaedics, Inc. · 2002
  • K021786Titanium Ankle Arthrodesis NailBiomet, Inc. · 20021 recall

More from Biomet Manufacturing Corp

201 FDA decisions under this applicant name. See the company

  • P010014/S119Cementless Oxford Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S118Oxford Partial Knee Anatomic Vivacit-E Meniscal BearingsBiomet Manufacturing Corp · 2026
  • P010014/S117Oxford™ Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S112Oxford Partial Knee System; Cementless Oxford™Partial Knee SystemBiomet Manufacturing Corp · 2026
  • P010014/S116Oxford® Partial Knee SystemBiomet Manufacturing Corp · 2026

Recent decisions in HSB

The HSB category page

  • K261189Freedom Nail Ankle Fusion SystemMcGinley Orthopaedic Innovations · 2026
  • K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp. · 2026
  • K261481Pangea Femur Reconstruction SystemStryker GmbH · 2026
  • K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp. · 2026
  • K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026

https://510kreport.com/device/K063570 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063570: Biomet Tibial Locking Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063570

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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