510(k) Report

510(k) · Cleared

Cleared

Suspension Acromioclavicular (AC) Repair System

K102143510(k) TraditionalCleared Dec 8, 2010131-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

Suspension Orthopaedic Solutions, LLC · JDR Staple, Fixation, Bone

Cleared on Dec 8, 2010 as substantially equivalent to K060970 (Axya Medical, Inc., 2006) and 3 other predicates after a 131-day review. Its family tree reaches back 4 generations to 2001.

Decided
Dec 8, 2010
Review
131 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K003227 (2001). 29 ancestors in all, the oldest K920213 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2005: 3 other ancestors1996: 3 other ancestors2004: 2 other ancestors2002: 2 other ancestors2001: 6 other ancestors1995: 1 other ancestor1992: 1 other ancestor2000: 4 other ancestors1998: 1 other ancestor1999: 1 other ancestorK003227 · Bio-Absorbable Corkscrew Model AR-1920B · Arthrex, Inc. · 2001K041698 · Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor · Axya Medical, Inc. · 2004K051250 · Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor · Axya Medical, Inc. · 2005K060970 · Axyaloop Nonabsorbable Bone Anchor · Axya Medical, Inc. · 2006 · recalled19901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 10 other ancestors3 generations back: 10 other ancestors4 generations back: 2 other ancestors K060970 · Axyaloop Nonabsorbable Bone Anchor · Axya Medical, Inc. · 2006 · recalledK051250 · Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor · Axya Medical, Inc. · 2005K041698 · Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor · Axya Medical, Inc. · 2004K003227 · Bio-Absorbable Corkscrew Model AR-1920B · Arthrex, Inc. · 20010
  1. Root · 4 generations backK003227 Bio-Absorbable Corkscrew Model AR-1920BArthrex, Inc. · 2001
  2. 3 generations backK041698 Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2004
  3. 2 generations backK051250 Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2005
  4. 1 generation backK060970 Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc. · 2006 · Recalled
  5. This deviceK102143 Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K003227Bio-Absorbable Corkscrew Model AR-1920BArthrex, Inc.2001—
−3K041698Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.2004—
−2K051250Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc.2005—
−1K060970Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc.200621
0 (this device)K102143Suspension Acromioclavicular (AC) Repair SystemSuspension Orthopaedic Solutions, LLC2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199510
199630
199810
199910
200040
200160
200220
200420
200530
200710
FIG. 1 — Lineage of K102143, 2001–2010Source: 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? (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
*K060970Axyaloop Nonabsorbable Bone Anchor
Summary page 1
…arities in indications for use, design, and material composition to the following currently marketed predicate device: " AxyaLoopTM" Noni-absorbable Bone Anchor (1(060970) * AxyaLoopTM Self Tapping Bone Anchor (1K05249 1) o Telc~lex Force Fiber Blue Co-Braided Polyethylene Suture (K(063778…
Axya Medical, Inc.200621
*K052491Axya Model 6500 Axyaloop Self-Tapping Bone Anchor
Summary page 1
…composition to the following currently marketed predicate device: " AxyaLoopTM" Noni-absorbable Bone Anchor (1(060970) * AxyaLoopTM Self Tapping Bone Anchor (1K05249 1) o Telc~lex Force Fiber Blue Co-Braided Polyethylene Suture (K(063778) * LM Anchor (K960825) Description of the Devic…
Axya Medical, Inc.200521
*K063778Force Fiber Polyethylene Nonabsorbable Suture
Summary page 1
…aLoopTM" Noni-absorbable Bone Anchor (1(060970) * AxyaLoopTM Self Tapping Bone Anchor (1K05249 1) o Telc~lex Force Fiber Blue Co-Braided Polyethylene Suture (K(063778) * LM Anchor (K960825) Description of the Device: The Suspension"" Acromioclavicular (AC) Repair System is an internal fix…
Teleflex Medical20071
*K960825LM Anchor or Other Proprietary Name
Summary page 1
…one Anchor (1(060970) * AxyaLoopTM Self Tapping Bone Anchor (1K05249 1) o Telc~lex Force Fiber Blue Co-Braided Polyethylene Suture (K(063778) * LM Anchor (K960825) Description of the Device: The Suspension"" Acromioclavicular (AC) Repair System is an internal fixation systemn consisting of…
Li Medical Technologies, Inc.1996—

Also cleared against K060970: 2 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 9 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
  • 8 of the 29 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K060970.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Suspension™ Acromioclavicular (AC) Repair System can be used for adult patients. The AC Repair System is indicated for securing suture to bone for acromioclavicular separations and coracoclavicular displacement.

Indications for use as stated in the FDA summary.

Also cleared against K060970

2 other devices cite the same predicate.

  • K222574Simparo Anchor Line Fixation SystemSimparo, Inc. · 2023
  • K083268Tornier, Inc., Insite Suture AnchorsTornier, Inc. · 2009

More from Suspension Orthopaedic Solutions, LLC

4 FDA decisions under this applicant name. See the company

  • K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC · 2012
  • K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC · 2011
  • K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC · 2010

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/K102143 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102143: Suspension Acromioclavicular (AC) Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102143

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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