510(k) · Cleared
ClearedAxya Medical Inc, Bone Anchor System 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 Sep 22, 1999 as substantially equivalent to K980988 (Axya Medical, Inc., 1998) and 2 other predicates after a 64-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Sep 22, 1999
- Review
- 64 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K932591 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK932591 Endo-JudgeSynergistic Medical Technologies, Inc. · 1993
- 2 generations backK980988 Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Axya Medical, Inc. · 1998
- 1 generation backK983108 Suture Welding System and Kit (SWK)Axya Medical, Inc. · 1998
- This deviceK992405 Axya Medical Inc, Bone Anchor System and Kit- (Bak)Axya Medical, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK994313 Modification to Bone Anchor and Kit (Bak)Axya Medical, Inc. · 2000
Most influential descendants
Showing 1 of 1 · See all- K994313Modification to Bone Anchor and Kit (Bak)Axya Medical, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932591 | Endo-Judge | Synergistic Medical Technologies, Inc. | 1993 | — |
| −2 | K980988 | Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls) | Axya Medical, Inc. | 1998 | — |
| −1 | K983108 | Suture Welding System and Kit (SWK) | Axya Medical, Inc. | 1998 | — |
| 0 (this device) | K992405 | Axya Medical Inc, Bone Anchor System and Kit- (Bak) | Axya Medical, Inc. | 1999 | — |
| +1 | K994313 | Modification to Bone Anchor and Kit (Bak) | Axya Medical, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
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 |
|---|---|---|---|
| * | K980988 | Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Summary page 1…n Product Name: Bone Anchor System and Kit (BAK) Classification: Accessory to an Endoscope - Class Il Predicate Devices Axya Suturing and Ligating System (ASLS) [510(k) K980988] Axya Suture Welding System and Kit (SWK) [510(k) K983108] Description The Axya Bone Anchor System consists of an electronic con… | 1998 |
| * | K983108 | Suture Welding System and Kit (SWK)Summary page 1…tion: Accessory to an Endoscope - Class Il Predicate Devices Axya Suturing and Ligating System (ASLS) [510(k) K980988] Axya Suture Welding System and Kit (SWK) [510(k) K983108] Description The Axya Bone Anchor System consists of an electronic control module and a reusable welding activator with an integr… | 1998 |
| * | K932591 | Endo-Judge Our OCR of the scanned summary read K832591, FDA’s number for Diacrom *PLG (Wellcome Diagnostics). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Endo-Judge disposable suture placement system”. | 1993 |
| † | K895252 | Ultracision Ultrasonic Scalpel | 1989 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K994313 | Modification to Bone Anchor and Kit (Bak) | 2000 | 0 |
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 6 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K994313 (Axya Medical, Inc., 2000) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K980988.
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/K992405 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992405: Axya Medical Inc, Bone Anchor System 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/K992405
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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