510(k) · Cleared
ClearedModification to Bone Anchor and Kit (Bak)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axya Medical, Inc. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on Jan 13, 2000 as substantially equivalent to K992405 (Axya Medical, Inc., 1999) and 2 other predicates after a 22-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Jan 13, 2000
- Review
- 22 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K932591 (1993). No later device cites it as a predicate yet.
- Root · 4 generations backK932591 Endo-JudgeSynergistic Medical Technologies, Inc. · 1993
- 3 generations backK980988 Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Axya Medical, Inc. · 1998
- 2 generations backK983108 Suture Welding System and Kit (SWK)Axya Medical, Inc. · 1998
- 1 generation backK992405 Axya Medical Inc, Bone Anchor System and Kit- (Bak)Axya Medical, Inc. · 1999
- This deviceK994313 Modification to Bone Anchor and Kit (Bak)Axya Medical, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932591 | Endo-Judge | Synergistic Medical Technologies, Inc. | 1993 | — |
| −3 | K980988 | Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls) | Axya Medical, Inc. | 1998 | — |
| −2 | K983108 | Suture Welding System and Kit (SWK) | Axya Medical, Inc. | 1998 | — |
| −1 | K992405 | Axya Medical Inc, Bone Anchor System and Kit- (Bak) | Axya Medical, Inc. | 1999 | — |
| 0 (this device) | K994313 | Modification to Bone Anchor and Kit (Bak) | Axya Medical, Inc. | 2000 | — |
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 GAW? 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 GAW device
- #1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992405 | Axya Medical Inc, Bone Anchor System and Kit- (Bak)Summary page 2…suture (manufactured by United States Surgical or Sharpoint) and a reusable welding sleeve is substantially equivalent to the original Bone Anchor System and Kit [501(k) K992405], and to the Axya Suturing and Ligating System (ASLS) [510(k) K980988], and the Axya Suture Welding System and Kit (SWK) [510(k)… | 1999 |
| * | K980988 | Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Summary page 1…on Product Name: Bone Anchor System and Kit (BAK) Classification: Accessory to an Endoscope - Class I Predicate Devices Axya Suturing and Ligating System (ASLS) [510(k) K980988] Axya Suture Welding System and Kit (SWK) [510(k) KS83108] Description The Axya Bone Anchor System consists of an electronic con… | 1998 |
| * | K983108 | Suture Welding System and Kit (SWK)Summary page 2…ne Anchor System and Kit [501(k) K992405], and to the Axya Suturing and Ligating System (ASLS) [510(k) K980988], and the Axya Suture Welding System and Kit (SWK) [510(k) K983108]; and that it is appropriate for its intended application. Suture applicators and suture placement devices which may be used in b… | 1998 |
| † | K895252 | Ultracision Ultrasonic Scalpel | 1989 |
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 7 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
MAUDE reports naming product code GAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The Bone Anchor System and Kit is indicated for securing soft tissue structures to bone anchors in surgical procedures where bone anchors are indicated. Examples of these procedures include:
Shoulder procedures (e.g. Rotator cuff repair)
Knee procedures (e.g. Patellar ligament / tendon avulsion repair)
Ankle procedures (e.g. Achilles tendon reconstruction and repair)
Foot procedures (e.g. Hallux valgus reconstruction)
Elbow procedures (e.g. Biceps tendon reattachment)
Bladder neck suspension (female urinary incontinence due to urethral hypermobility)
The BAK is indicated for use in both traditional open surgery and endoscopic surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994313 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994313: Modification to Bone Anchor and Kit (Bak).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994313
Report an extraction error
Are you the manufacturer?
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