510(k) Report

510(k) · Cleared

Cleared

Pro Fixation System

K110538510(k) TraditionalCleared Jul 12, 2011137-day reviewClass II21 CFR 888.3040

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

Synovis Orthopedic & Woundcare · HWC Screw, Fixation, Bone

Cleared on Jul 12, 2011 as substantially equivalent to K051219 (Arthrex, Inc., 2005) and 5 other predicates after a 137-day review. Its family tree reaches back 4 generations to 1997.

Decided
Jul 12, 2011
Review
137 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K971723 (1997). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2005: 2 other ancestors2004: 1 other ancestor2001: 2 other ancestors2000: 2 other ancestorsK971723 · Fastak Suture Anchor (11.7MM)/(7.5MM) · Arthrex, Inc. · 1997K051219 · Pushlock · Arthrex, Inc. · 2005K073509 · Twinfix PK FP Suture Anchor · Smith & Nephew, Inc. · 2008K093897 · Smith & Nephew Footprint Ultra PK Suture Anchor · Smith & Nephew Inc., Endoscopy Div. · 2010 · recalled1995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 2 other ancestors K093897 · Smith & Nephew Footprint Ultra PK Suture Anchor · Smith & Nephew Inc., Endoscopy Div. · 2010 · recalledK073509 · Twinfix PK FP Suture Anchor · Smith & Nephew, Inc. · 2008K051219 · Pushlock · Arthrex, Inc. · 2005K971723 · Fastak Suture Anchor (11.7MM)/(7.5MM) · Arthrex, Inc. · 19970
  1. Root · 4 generations backK971723 Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc. · 1997
  2. 3 generations backK051219 PushlockArthrex, Inc. · 2005
  3. 2 generations backK073509 Twinfix PK FP Suture AnchorSmith & Nephew, Inc. · 2008
  4. 1 generation backK093897 Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 2010 · Recalled
  5. This deviceK110538 Pro Fixation SystemSynovis Orthopedic & Woundcare · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K971723Fastak Suture Anchor (11.7MM)/(7.5MM)Arthrex, Inc.1997—
−3K051219PushlockArthrex, Inc.2005—
−2K073509Twinfix PK FP Suture AnchorSmith & Nephew, Inc.2008—
−1K093897Smith & Nephew Footprint Ultra PK Suture AnchorSmith & Nephew Inc., Endoscopy Div.20102
0 (this device)K110538Pro Fixation SystemSynovis Orthopedic & Woundcare2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200120
200410
200520
200610
FIG. 1 — Lineage of K110538, 1997–2011Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (6)

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
*K051219Pushlock
Summary page 1
…ly equivalent to the following devices, which are cleared for commercial distribution in the United States: o lPL-ockT~I , Arthrex, Inc.. K05 1219 " Arthrex Tenodesis Family, Arthr-ex. Inc, K05 1726 o Corkscrew FT, Arthrex. Inc., K050358, K06…
Arthrex, Inc.2005—
*K051726Arthrex Tenodesis Family
Summary page 1
…ared for commercial distribution in the United States: o lPL-ockT~I , Arthrex, Inc.. K05 1219 " Arthrex Tenodesis Family, Arthr-ex. Inc, K05 1726 o Corkscrew FT, Arthrex. Inc., K050358, K06 1665 * FOOTPRINT Ultra 1PK Suture Anchor, Smith & N…
Arthrex, Inc.2005—
*K050358Artherx Corkscrew FT II Suture Anchor
Summary page 1
…o lPL-ockT~I , Arthrex, Inc.. K05 1219 " Arthrex Tenodesis Family, Arthr-ex. Inc, K05 1726 o Corkscrew FT, Arthrex. Inc., K050358, K06 1665 * FOOTPRINT Ultra 1PK Suture Anchor, Smith & Nephiew, hIc., Enidoscopy Division, K07…
Arthrex, Inc.2005—
*K061665Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT
Summary page 1
…o lPL-ockT~I , Arthrex, Inc.. K05 1219 " Arthrex Tenodesis Family, Arthr-ex. Inc, K05 1726 o Corkscrew FT, Arthrex. Inc., K050358, K06 1665 * FOOTPRINT Ultra 1PK Suture Anchor, Smith & Nephiew, hIc., Enidoscopy Division, K07'3509/ K09…
Arthrex, Inc.2006—
*K073509Twinfix PK FP Suture AnchorSmith & Nephew, Inc.2008—
*K093897Smith & Nephew Footprint Ultra PK Suture Anchor
Summary page 1
…kscrew FT, Arthrex. Inc., K050358, K06 1665 * FOOTPRINT Ultra 1PK Suture Anchor, Smith & Nephiew, hIc., Enidoscopy Division, K07'3509/ K093897 4 Device Descr-iption The PRO FixationIT~i System is a sterile single use device intended for the…
Smith & Nephew Inc., Endoscopy Div.20102

Also cleared against K051219: 13 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 14 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • 13 other devices also cite its predicate K051219.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

Intended for the reattachment of soft tissue to bone in the shoulder, foot/ankle, knee, elbow and hand/wrist for the following indications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-Foot…

Read the full statement (126 words)

Intended for the reattachment of soft tissue to bone in the shoulder, foot/ankle, knee, elbow and hand/wrist for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-Foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction and Repair, Tendon Transfer in the Hand/Wrist

Indications for use as stated in the FDA summary.

Also cleared against K051219

13 other devices cite the same predicate.

  • K203334The Citrefix Knotless Suture AnchorAcuitive Technologies, Inc. · 2021
  • K191242HEALIX ADVANCE SP BIOCOMPOSITE AnchorMedos International SARL · 2019
  • K182941HEALIX ADVANCE SP PEEK AnchorMedos International SARL · 2019
  • K180101HEALIX ADVANCE KNOTLESS BR AnchorMedos International SARL · 2018
  • K171114HEALIX ADVANCE KNOTLESS AnchorMedos International SARL · 2017
  • K133235Threaded Peek K-WireMtp Solutions, LLC · 2014

More from Synovis Orthopedic & Woundcare

3 FDA decisions under this applicant name. See the company

  • K113460Synergy Tissue MatrixSynovis Orthopedic & Woundcare · 2012
  • K112399Unite BiomatrixSynovis Orthopedic & Woundcare · 2011

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The HWC category page

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https://510kreport.com/device/K110538 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110538: Pro 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/K110538

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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