510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

SnapShot Fixation System

K143037510(k) TraditionalCleared Jan 20, 201590-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

Biomet Manufacturing Corp · JDR Staple, Fixation, Bone

Cleared on Jan 20, 2015 as substantially equivalent to K981798 (Biomet, Inc., 1998) after a 90-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it. It has been recalled once.

Decided
Jan 20, 2015
Review
90 days
Class
Class II
Product code
JDR
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K981798 (1998). 2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2026: 2 descendants clearedReference device: K070389 · Peek Knotless Anchors · Biomet Sports Medicine, Inc. · 2007 · recalledK981798 · Lactosorb Pop Rivet · Biomet, Inc. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant K981798 · Lactosorb Pop Rivet · Biomet, Inc. · 19980
  1. Root · 1 generation backK981798 Lactosorb Pop RivetBiomet, Inc. · 1998
  2. This deviceK143037 SnapShot Fixation SystemBiomet Manufacturing Corp · 2015
  3. Descendant · cites it directly · 1 of its ownK252635 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026
  4. Descendant · 2 generations on · 0 of its ownK262809 ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

Most influential descendants

Showing 2 of 2 · See all
  • K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026 · cites it directly1descendant
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K981798Lactosorb Pop RivetBiomet, Inc.1998—
0 (this device)K143037SnapShot Fixation SystemBiomet Manufacturing Corp2015—
+1K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC2026—
+2K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202620
FIG. 1 — Lineage of K143037, 1998–2026Source: 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
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What was it cleared against? (1)

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
*K981798Lactosorb Pop Rivet
Summary page 4
…lassification Name: JDR - Staple, Fixation, Bone (21 CFR 888.3030) Legally marketed devices to which substantial equivalence is claimed: Biomet Lactosorb Pop Rivet (K981798) Biomet PEEK Knotless Anchor (K070389) – reference for materials Device Description The SnapShot Fixation System consists…
Biomet, Inc.1998—
†K070389Peek Knotless AnchorsBiomet Sports Medicine, Inc.20071

Also cleared against K981798: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K252635ArthroTAK Tendon Anchor KitArthroTAK, LLC20261

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 25, 2017Class IIZ-1009-2018Process controlIt was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K252635 (ArthroTAK, LLC, 2026) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K981798.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 SnapShot Fixation System is indicated for use in soft tissue reattachment procedures in the following shoulder procedures:

Bankart repair, SLAP repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, and deltoid repair.

The SnapShot Fixation System is also indicated for supplementary fixation when used in conjunction with a primary fixation device in surgical procedures requiring graft fixation.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K143037: SnapShot 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/K143037

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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