510(k) Report

510(k) · Cleared

Cleared

Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System

K051965510(k) TraditionalCleared Jun 16, 2006331-day reviewClass II21 CFR 888.3020

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

Merete Medical GmbH · HSB Rod, Fixation, Intramedullary And Accessories

Cleared on Jun 16, 2006 as substantially equivalent to K934643 (Ace Orthopedic Manufacturing Co., 1994) and 8 other predicates after a 331-day review. Its family tree reaches back 2 generations to 1996. 3 later devices descend from it.

Decided
Jun 16, 2006
Review
331 days
Class
Class II
Product code
HSB
Recalls
None
Predicates
9

Its longest line of descent runs back 2 generations to K962553 (1996). 10 ancestors in all, the oldest K853250 (1986). 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1994: 2 other ancestors1992: 1 other ancestor1989: 1 other ancestor1988: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestor2015: 1 descendant cleared2010: 1 descendant cleared2018: 1 descendant clearedK962553 · EZ-Fix Midshaft Humeral Intramedullary Rod System · Biodynamic Technologies, Inc. · 1996K980609 · Segmental Defect Replacement System · Metagen, LLC · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K980609 · Segmental Defect Replacement System · Metagen, LLC · 1998K962553 · EZ-Fix Midshaft Humeral Intramedullary Rod System · Biodynamic Technologies, Inc. · 19960
  1. Root · 2 generations backK962553 EZ-Fix Midshaft Humeral Intramedullary Rod SystemBiodynamic Technologies, Inc. · 1996
  2. 1 generation backK980609 Segmental Defect Replacement SystemMetagen, LLC · 1998
  3. This deviceK051965 Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation…Merete Medical GmbH · 2006
  4. Descendant · cites it directly · 1 of its ownK142451 OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect…Merete Medical GmbH · 2015
  5. Descendant · 2 generations on · 0 of its ownK181026 OsteoBridge™ IDSF SystemMerete GmbH · 2018 · Recalled
  6. Descendant · cites it directly · 0 of its ownK101939 Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH · 2010 · Recalled

Most influential descendants

Showing 3 of 3 · See all
  • K142451OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH · 2015 · cites it directly1descendant
  • K181026OsteoBridge™ IDSF SystemMerete GmbH · 2018 · 2 generations on0descendants
  • K101939Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K962553EZ-Fix Midshaft Humeral Intramedullary Rod SystemBiodynamic Technologies, Inc.1996—
−1K980609Segmental Defect Replacement SystemMetagen, LLC1998—
0 (this device)K051965Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH2006—
+1K142451OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod…Merete Medical GmbH2015—
+2K181026OsteoBridge™ IDSF SystemMerete GmbH20183
+1K101939Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH20101

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198710
198810
198910
199210
199420
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201510
201810
FIG. 1 — Lineage of K051965, 1996–2018Source: 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? (9)

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
*K934643Ace Humeral Nail
Summary page 1
…HSB Proposed Reguhatory Class: Class II Predicate Device± -ACE Aim Humneral Nail (K(934643) Ace Aim Tibial Nai] (K934643) Zindrick IM Rod (K882443); Later named ACE AIM Femoral Nail…
Ace Orthopedic Manufacturing Co.1994—
*K882443Zindrick IM Rod Instruments
Summary page 1
…Reguhatory Class: Class II Predicate Device± -ACE Aim Humneral Nail (K(934643) Ace Aim Tibial Nai] (K934643) Zindrick IM Rod (K882443); Later named ACE AIM Femoral Nail (K871539) -Synth…
Buckman Co., Inc.1988—
*K871539Zindrick IM Rod
Summary page 1
…Aim Tibial Nai] (K934643) Zindrick IM Rod (K882443); Later named ACE AIM Femoral Nail (K871539) -Synthes Unreamed Humeral Nail (UHM) (K9335 18) -Synthes Unreamed Tibial Nail (UTN) (K914453) -Russell-T…
Buckman Co., Inc.19871
*K933518Synthes Unreamed Humeral Nail (Urhn)
Summary page 1
…82443); Later named ACE AIM Femoral Nail (K871539) -Synthes Unreamed Humeral Nail (UHM) (K9335 18) -Synthes Unreamed Tibial Nail (UTN) (K914453) -Russell-Taylor Femoral Nail (K893377) -Metagen Segment…
Synthes (Usa)1994—
*K914453Universal Tibial Nail and Unreamed Tibial Nail
Summary page 1
…(K871539) -Synthes Unreamed Humeral Nail (UHM) (K9335 18) -Synthes Unreamed Tibial Nail (UTN) (K914453) -Russell-Taylor Femoral Nail (K893377) -Metagen Segmental Defect Replacement System (K980609) -Howmedica…
Synthes (Usa)1992—
*K893377Russell-Taylor Intramedullary Knee Fusion Nails
Summary page 1
…(K871539) -Synthes Unreamed Humeral Nail (UHM) (K9335 18) -Synthes Unreamed Tibial Nail (UTN) (K914453) -Russell-Taylor Femoral Nail (K893377) -Metagen Segmental Defect Replacement System (K980609) -Howmedica Modular Proximal Humerus Replacement Syst…
Richards Medical Co., Inc.1989—
*K980609Segmental Defect Replacement System
Summary page 1
…(K9335 18) -Synthes Unreamed Tibial Nail (UTN) (K914453) -Russell-Taylor Femoral Nail (K893377) -Metagen Segmental Defect Replacement System (K980609) -Howmedica Modular Proximal Humerus Replacement System (K(954559) Zimnmer Femorotibial Medullary Nail (K(85…
Metagen, LLC1998—
*K954559Howmedicca Modular Proximal Humerus Replacement System
Summary page 1
…ell-Taylor Femoral Nail (K893377) -Metagen Segmental Defect Replacement System (K980609) -Howmedica Modular Proximal Humerus Replacement System (K(954559) Zimnmer Femorotibial Medullary Nail (K(853250) Clinically Related Devices: - Modular Oncology System Technology (…
Howmedica Corp.1996—
*K853250Femorotibial Medullary Nail
Summary page 1
…gmental Defect Replacement System (K980609) -Howmedica Modular Proximal Humerus Replacement System (K(954559) Zimnmer Femorotibial Medullary Nail (K(853250) Clinically Related Devices: - Modular Oncology System Technology (K960626) - SOS Proximnal Femur (K933281) - Modu…
Zimmer, Inc.19861

Also cleared against K934643: 1 other device →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K142451OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH20151
K101939Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH20100

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 10 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
  • 2 of the 10 ancestors have a recall of any class.
  • Of its descendants, K142451 (Merete Medical GmbH, 2015) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K934643.

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.

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 device is intended to be used in the management of segmental diaphyseal bone loss of either humerus or tibia or femur in oncology patients secondary to radical bone loss and/or resection due to tumors. The intramedullary rods can be fixed with interlocking screws without or with bone cement.

Indications for use as stated in the FDA summary.

Also cleared against K934643

1 other device cites the same predicate.

  • K033878Ace Antegrade Retrograde Humeral Nail SystemDepuy Ace · 2004

More from Merete Medical GmbH

24 FDA decisions under this applicant name. See the company

  • K160548MC-Subtalar (TM) IIMerete Medical GmbH · 2016
  • K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS…Merete Medical GmbH · 2016
  • K151762PediatrOS RigidTack/FlexTackMerete Medical GmbH · 20151 recall
  • K142451OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH · 2015
  • K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH · 2014

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/K051965 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051965: Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051965

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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