510(k) · Cleared

Cleared

Nexfix Compression Staple

K070688510(k) TraditionalCleared May 18, 200767-day reviewClass II21 CFR 888.3030

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

Nexa Orthopedics, Inc. · JDR Staple, Fixation, Bone

Cleared on May 18, 2007 as substantially equivalent to K043059 (Wrightmedicaltechnologyinc, 2005) and 2 other predicates after a 67-day review. Its family tree reaches back 3 generations to 1997.

Decided: May 18, 2007
Review: 67 days
Class: Class II
Product code: JDR
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K964226 (1997). 9 ancestors in all, the oldest K895117 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK964226 Memory Staple (20 Sizes Available)Landos, Inc. · 1997
2 generations backK991482 Uni-Clip StapleNew Deal, S.A. · 1999
1 generation backK011716 The Uni-Clip StapleNew Deal, S.A. · 2001 · Recalled
This deviceK070688 Nexfix Compression StapleNexa Orthopedics, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K964226	Memory Staple (20 Sizes Available)	Landos, Inc.	1997	—
−2	K991482	Uni-Clip Staple	New Deal, S.A.	1999	—
−1	K011716	The Uni-Clip Staple	New Deal, S.A.	2001	1
0 (this device)	K070688	Nexfix Compression Staple	Nexa Orthopedics, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	2	0
2000	2	0
2005	1	0
2006	1	0

FIG. 1 — Lineage of K070688, 1997–2007Source: 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 JDR? 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 JDR device

#1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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
*	K043059	Compression Staple and Simple Staple Summary page 1 …9028319 Legally marketed device to which substantial equivalence is claimed: The legally marketed devices to which substantial equivalence is claimed are the K043059 Wright Medical Compression Staple and simple staple, K01 1716 New Deal UniClip Staple, and K060014 Intelifuse Warmsystem with Sti…	Wrightmedicaltechnologyinc	2005	—
*	K011716	The Uni-Clip Staple Summary page 1 …ial equivalence is claimed: The legally marketed devices to which substantial equivalence is claimed are the K043059 Wright Medical Compression Staple and simple staple, K01 1716 New Deal UniClip Staple, and K060014 Intelifuse Warmsystem with StimuLinks Device Description: The Nexa Orthopedics NexFixTM Com…	New Deal, S.A.	2001	1
*	K060014	Intelifuse, Inc., Warmsystem with Stimulinks Summary page 1 …y marketed devices to which substantial equivalence is claimed are the K043059 Wright Medical Compression Staple and simple staple, K01 1716 New Deal UniClip Staple, and K060014 Intelifuse Warmsystem with StimuLinks Device Description: The Nexa Orthopedics NexFixTM Compression Staple is made of Stainless…	Intelifuse, Inc.	2006	—

Also cleared against K043059: 9 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 2.2 years on median.
2 of the 9 ancestors have a recall of any class.
9 other devices also cite its predicate K043059.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · JDR

3in 2025

2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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	70	0	3
2008	5	89	1	14
2009	0	—	0	10
2010	2	—	0	35
2011	1	—	0	62
2012	1	—	0	34
2013	9	137	0	27
2014	11	97	0	49
2015	7	111	1	48
2016	6	101	0	76
2017	9	172	0	116
2018	8	107	1	239
2019	5	149	0	242
2020	4	161	1	234
2021	3	62	0	210
2022	5	107	11	202
2023	9	72	0	175
2024	4	29	0	206
2025	3	65	0	314
2026	2	—	2	—

What is it indicated for?

The NexFixTM Compression Staple is indicated for fixation of fracture, fusion, and osteotomies of the hand, fore foot, mid foot and hind foot.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070688 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070688: Nexfix Compression Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070688

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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