510(k) Report

FDA applicant

Axya Medical, Inc.

Beverly, MA19 decisions1998–200721 recalls

FDA records 19 decisions for Axya Medical, Inc. (Beverly, MA) from 1998 to 2007: 19 510(k) clearances. Most are in product codes GAW (Suture, Nonabsorbable, Synthetic, Polypropylene) and MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Its devices cite 35 predicates, 15 of them its own earlier devices. 21 recalls are linked to its devices.

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

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Axya Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

21in 2007

2007: 21
2007high 21 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Axya Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Axya Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GAWSuture, Nonabsorbable, Synthetic, Polypropylene5decisions
  • MBIFastener, Fixation, Nondegradable, Soft Tissue5decisions
  • MAIFastener, Fixation, Biodegradable, Soft Tissue3decisions
  • GATSuture, Nonabsorbable, Synthetic, Polyethylene3decisions
  • GABNeedle, Suturing, Disposable1decision
  • JDRStaple, Fixation, Bone1decision

Also: LFL (1).

Whose devices does it build on?

Its devices cite 35 predicates; 15 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 26 times; 15 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K041698Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 20045cite it
  • K980988Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Axya Medical, Inc. · 19983cite it
  • K060970Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc. · 20063cite it
  • K983108Suture Welding System and Kit (SWK)Axya Medical, Inc. · 19983cite it
  • K051983Model 3000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 20052cite it
  • K011912Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000Axya Medical, Inc. · 20012cite it

What has FDA decided for it lately?

  • K070773Axya, Model 3000 Axyzloop Titanium Bone AnchorAxya Medical, Inc. · 2007
  • K070253Axya Suture Welding System and KitAxya Medical, Inc. · 2007
  • K063194Tufflex Polyester SutureAxya Medical, Inc. · 2006
  • K060165Axyaflex Polyester SutureAxya Medical, Inc. · 2006
  • K060970Axyaloop Nonabsorbable Bone AnchorAxya Medical, Inc. · 200621 recalls
  • K052491Axya Model 6500 Axyaloop Self-Tapping Bone AnchorAxya Medical, Inc. · 200521 recalls
  • K051983Model 3000 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 200521 recalls
  • K051250Axya, Model 6500 Axyaloop Bio-Absorbable Bone AnchorAxya Medical, Inc. · 2005

All 19 as Axya Medical, Inc. →

What has been recalled?

21 recalls linked to its devices; the latest:

  • K051983Axya Bone Anchor 5.0 mm Titanium with UHMWPE Suture Catalog Number: CAT1269, Axya…Sep 27, 2007
  • K051983Axya Bone Anchor 6.5 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1265, Axya…Sep 27, 2007
  • K051983Axya Bone Anchor 5.0 mm Bioabsorbable with UHMWPE Suture, Catalog Number: CAT1267, Axya…Sep 27, 2007
  • K051983Arthrocare 5mm ParaFix Anchor, 2 strands of MagnumWire Part Number: 22-5011, Axya…Sep 27, 2007
  • K051983Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid)…Sep 27, 2007
  • K051983Axya Bone Anchor 5.0 mm Bioabsorbable with Nylon Suture Catalog Number: CAT1234, Axya…Sep 27, 2007