510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

JAWS (TM) Nitinol Staple System

K170923510(k) TraditionalCleared Jul 24, 2017117-day reviewClass II21 CFR 888.3030Recalls 1

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

Paragon 28 · JDR Staple, Fixation, Bone

Cleared on Jul 24, 2017 as substantially equivalent to K001354 (Biomedical Ent., Inc., 2001) and 3 other predicates after a 117-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it. It has been recalled once.

Decided
Jul 24, 2017
Review
117 days
Class
Class II
Product code
JDR
Recalls
1
Predicates
4

Its longest line of descent runs back 1 generation to K001354 (2001). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2006: 1 other ancestor2001: 1 other ancestor2023: 2 descendants cleared2026: 1 descendant clearedK001354 · Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System · Biomedical Ent., Inc. · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K001354 · Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System · Biomedical Ent., Inc. · 20010
  1. Root · 1 generation backK001354 Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment…Biomedical Ent., Inc. · 2001
  2. This deviceK170923 JAWS (TM) Nitinol Staple SystemParagon 28 · 2017
  3. Descendant · cites it directly · 2 of its ownK223056 JAWS Nitinol Staple SystemParagon 28, Inc. · 2023
  4. Descendant · 2 generations on · 1 of its ownK230550 JAWS Nitinol Staple SystemParagon 28, Inc. · 2023
  5. Descendant · 3 generations on · 0 of its ownK261121 Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026

Most influential descendants

Showing 3 of 3 · See all
  • K223056JAWS Nitinol Staple SystemParagon 28, Inc. · 2023 · cites it directly2descendants
  • K230550JAWS Nitinol Staple SystemParagon 28, Inc. · 2023 · 2 generations on1descendant
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001354Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for…Biomedical Ent., Inc.2001—
0 (this device)K170923JAWS (TM) Nitinol Staple SystemParagon 282017—
+1K223056JAWS Nitinol Staple SystemParagon 28, Inc.2023—
+2K230550JAWS Nitinol Staple SystemParagon 28, Inc.2023—
+3K261121Megalodon Dynamic Compression SystemParagon 28, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200610
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202320
202610
FIG. 1 — Lineage of K170923, 2001–2026Source: 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 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. #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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? (4)

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
*K001354Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the…
Summary page 5
…The JAWS™ Nitinol Staple System implants are made from Nitinol (ASTM F2063). Primary Predicate: OSStaple (BioMedical Enterprises, Inc. – K001354) Additional Predicates: Biopro Memory Staple (Biopro, Inc. – K061798), Memodyn Staple (Telos Medical E…
Biomedical Ent., Inc.2001—
*K061798Biopro Memory Staple
Summary page 5
…(ASTM F2063). Primary Predicate: OSStaple (BioMedical Enterprises, Inc. – K001354) Additional Predicates: Biopro Memory Staple (Biopro, Inc. – K061798), Memodyn Staple (Telos Medical Equipment – K002695), Super Staple™ Classic (Me…
Biopro, Inc.2006—
*K002695Memodyn Staple
Summary page 5
…l Enterprises, Inc. – K001354) Additional Predicates: Biopro Memory Staple (Biopro, Inc. – K061798), Memodyn Staple (Telos Medical Equipment – K002695), Super Staple™ Classic (Metric Medical Devices, Inc. – K123363) Performance Data: Static and dyn…
Telos Medical Equipment2001—
*K123363Super Staple (TM) Classic
Summary page 5
…. – K061798), Memodyn Staple (Telos Medical Equipment – K002695), Super Staple™ Classic (Metric Medical Devices, Inc. – K123363) Performance Data: Static and dynamic bending, and pullout fixation strength testing was performe…
Metric Medical Devices, Inc.2013—

Also cleared against K001354: 6 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K223056JAWS Nitinol Staple SystemParagon 28, Inc.20232

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 19, 2017Class IIZ-2261-2018Error in labelingMissing drill guide as stated in the package.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K223056 (Paragon 28, Inc., 2023) has gone furthest, with 2 descendants of its own.
  • 6 other devices also cite its predicate K001354.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · JDR

3in 2025

2007: 82008: 52010: 22011: 12012: 12013: 92014: 112015: 72016: 62017: 92018: 82019: 52020: 42021: 32022: 52023: 92024: 42025: 32026 (partial year): 2
2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007: 70 days median2008: 89 days median2013: 137 days median2014: 97 days median2015: 111 days median2016: 101 days median2017: 172 days median2018: 107 days median2019: 149 days median2020: 161 days median2021: 62 days median2022: 107 days median2023: 72 days median2024: 29 days median2025: 65 days median
2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2008: 12015: 12018: 12020: 12022: 112026 (partial year): 2
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

2007: 32008: 142009: 102010: 352011: 622012: 342013: 272014: 492015: 482016: 762017: 1162018: 2392019: 2422020: 2342021: 2102022: 2022023: 1752024: 2062025: 314
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200787003
2008589114
20090—010
20102—035
20111—062
20121—034
20139137027
20141197049
20157111148
20166101076
201791720116
201881071239
201951490242
202041611234
20213620210
2022510711202
20239720175
20244290206
20253650314
20262—2—

What is it indicated for?

The JAWS™ Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of bones and joint of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.

Indications for use as stated in the FDA summary.

Also cleared against K001354

6 other devices cite the same predicate.

  • K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 20143 recalls
  • K122871Compressyn StapleDallen Medical, Inc. · 2013
  • K071477Reverto 55 and 37 Shape Memory StaplesCore Essence Orthopaedics, LLC · 2007
  • K023488Osstaple, CraniofacialBiomedical Enterprises, Inc. · 2002
  • K023486Osstaple, MaxillofacialBiomedical Enterprises, Inc. · 2002
  • K023203OsstapleBiomedical Ent., Inc. · 2002

More from Paragon 28

7 FDA decisions under this applicant name. See the company

  • K171715HammerTube SystemParagon 28 · 20181 recall
  • K172886Breakaway Screw SystemParagon 28 · 2017
  • K162241TITAN 3-D™ Wedge SystemParagon 28 · 20171 recall
  • K153378Monster BITE Screw SystemParagon 28 · 2015
  • K151418Monster Screw SystemParagon 28 · 2015

Recent decisions in JDR

The JDR category page

  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K250712Linkt Compression Staple SystemTrax Surgical · 2025
  • K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
  • K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025

https://510kreport.com/device/K170923 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170923: JAWS (TM) Nitinol 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/K170923

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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