510(k) · Cleared

Cleared

Orthohelix Staple System

K142148510(k) SpecialCleared Aug 21, 201416-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

Orthohelix Surgical Designs, Inc. · JDR Staple, Fixation, Bone

Cleared on Aug 21, 2014 as substantially equivalent to K130832 (Orthohelix Surgical Designs, Inc., 2013) and 2 other predicates after a 16-day review. Its family tree reaches back 4 generations to 1990.

Decided: Aug 21, 2014
Review: 16 days
Class: Class II
Product code: JDR
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K902307 (1990). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
3 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
2 generations backK070031 Memometal Memory StaplesMemometal Technologies · 2007
1 generation backK130832 Orthohelix Staple SystemOrthohelix Surgical Designs, Inc. · 2013
This deviceK142148 Orthohelix Staple SystemOrthohelix Surgical Designs, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K902307	Shaw II Hemostatic Surgery System	Hemostatic Surgery Corp.	1990	2
−3	K993714	Memograph Staple, Warm System	Biomedical Ent., Inc.	2000	—
−2	K070031	Memometal Memory Staples	Memometal Technologies	2007	—
−1	K130832	Orthohelix Staple System	Orthohelix Surgical Designs, Inc.	2013	—
0 (this device)	K142148	Orthohelix Staple System	Orthohelix Surgical Designs, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K142148, 1990–2014Source: 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
*	K130832	Orthohelix Staple System Summary page 4 … SubstantialEquivalence: The new OrthoHelix staples are substantially equivalent to the existing Orthohelix Staple System (K130832), the Stryker (Memometal Technologies) EasyClip Staple (K070031), and the BioMedical Enter…	Orthohelix Surgical Designs, Inc.	2013	—
*	K070031	Memometal Memory Staples Summary page 4 …he existing Orthohelix Staple System (K130832), the Stryker (Memometal Technologies) EasyClip Staple (K070031), and the BioMedical Enterprises Inc. Speed Staple (K993714).Thissubmissionisamodificati…	Memometal Technologies	2007	—
*	K993714	Memograph Staple, Warm System Summary page 4 …(Memometal Technologies) EasyClip Staple (K070031), and the BioMedical Enterprises Inc. Speed Staple (K993714).ThissubmissionisamodificationtotheOrthoHelixStapleSystemto addnewstaplesizes.TheOrt…	Biomedical Ent., Inc.	2000	—

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 24 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
1 of the 5 ancestors has a recall of any class.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142148 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142148: Orthohelix Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142148

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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