510(k) · Cleared

Recalled · Class II · 2020

Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System

K101939510(k) TraditionalCleared Oct 7, 201087-day reviewClass II21 CFR 888.3020Recalls 1

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 Oct 7, 2010 as substantially equivalent to K051965 (Merete Medical GmbH, 2006) and 2 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1996. It has been recalled once.

Decided: Oct 7, 2010
Review: 87 days
Class: Class II
Product code: HSB
Recalls: 1
Predicates: 3

Its longest line of descent runs back 3 generations to K962553 (1996). 13 ancestors in all, the oldest K853250 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK962553 EZ-Fix Midshaft Humeral Intramedullary Rod SystemBiodynamic Technologies, Inc. · 1996
2 generations backK980609 Segmental Defect Replacement SystemMetagen, LLC · 1998
1 generation backK051965 Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation…Merete Medical GmbH · 2006
This deviceK101939 Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation SystemMerete Medical GmbH · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K962553	EZ-Fix Midshaft Humeral Intramedullary Rod System	Biodynamic Technologies, Inc.	1996	—
−2	K980609	Segmental Defect Replacement System	Metagen, LLC	1998	—
−1	K051965	Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System	Merete Medical GmbH	2006	—
0 (this device)	K101939	Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System	Merete Medical GmbH	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1987	1	0
1988	1	0
1989	1	0
1992	1	0
1994	2	0
1996	1	0
1998	1	0
2005	1	0

FIG. 1 — Lineage of K101939, 1996–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K051965	Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System Summary page 1 …71394 Kernen-Rommelshausen Certificates are enclosed in A nnex III Predicate Device: OsteoBridge® WISE Fixation Rod System (K051965) Femorotibial Medullary Nail ZimmerlInc. (K853250) Knee Fusion Nail, Smith &Nephew, Inc. (K050938) Device Description:…	Merete Medical GmbH	2006	—
*	K853250	Femorotibial Medullary Nail Summary page 1 …Certificates are enclosed in A nnex III Predicate Device: OsteoBridge® WISE Fixation Rod System (K051965) Femorotibial Medullary Nail ZimmerlInc. (K853250) Knee Fusion Nail, Smith &Nephew, Inc. (K050938) Device Description: OsteoBridge® Intramedullary Knee Arthrodesis Rod Fixa…	Zimmer, Inc.	1986	1
*	K050938	Knee Fusion Nail Summary page 1 …redicate Device: OsteoBridge® WISE Fixation Rod System (K051965) Femorotibial Medullary Nail ZimmerlInc. (K853250) Knee Fusion Nail, Smith &Nephew, Inc. (K050938) Device Description: OsteoBridge® Intramedullary Knee Arthrodesis Rod Fixation System (IKA) is a series of modular intramedullar…	Smith & Nephew, Inc.	2005	—

Also cleared against K051965: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 18, 2020	Class II	Z-0435-2021	Process design	Product may be mislabeled.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
2 of the 13 ancestors have a recall of any class.
1 other device also cites its predicate K051965.

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. 2010, this device’s year, is highlighted.

FDA decisions per year · HSB

15in 2025

2007high 23 (2017) · low 8 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSB

106in 2025

2007high 195 (2024) · low 57 (2008)2026

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

Recalls per year · HSB

18in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	68	0	162
2008	11	57	9	184
2009	18	86	81	334
2010	14	117	18	454
2011	16	78	2	662
2012	17	112	7	1,079
2013	18	105	14	1,773
2014	19	147	3	1,474
2015	22	111	3	1,671
2016	8	124	6	1,920
2017	23	119	66	1,447
2018	17	134	56	3,526
2019	13	132	6	2,517
2020	17	112	6	3,299
2021	10	94	2	4,111
2022	12	172	1	2,733
2023	11	162	1	2,219
2024	13	195	1	2,869
2025	15	106	18	2,911
2026	18	151	1	—

What is it indicated for?

Intramedullary knee arthrodesis

Indications include:

1. Irretrievably failed total knee arthroplasty

2. Limb salvage

3. Oncology surgery

4. Any other condition where there is little soft tissue or bony tissue available for support and arthrodesis is the treatment of choice

The intramedullary rods can be fixed with interlocking screws without or with bone cement.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101939 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101939: Osteobridge Ika Intramedullary Knee Arthrodesis Rod Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101939

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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