510(k) · Cleared
Recalled · Class II · 2018Phantom Fiber Biofiber Suture
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · NWJ Suture, Recombinant Technology
Cleared on Apr 4, 2013 as substantially equivalent to K122487 (Tornier, Inc., 2012) after a 43-day review. Its family tree reaches back 2 generations to 2007. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 4, 2013
- Review
- 43 days
- Class
- Class II
- Product code
- NWJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN060003 (2007). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN060003 Tephaflex Absorbable SutureTepha, Inc. · 2007
- 1 generation backK122487 Biofiber SytureTornier, Inc. · 2012
- This deviceK130422 Phantom Fiber Biofiber SutureTornier, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK132348 Tephaflex Braided SutureTepha, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132348Tephaflex Braided SutureTepha, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN060003 | Tephaflex Absorbable Suture | Tepha, Inc. | 2007 | — |
| −1 | K122487 | Biofiber Syture | Tornier, Inc. | 2012 | — |
| 0 (this device) | K130422 | Phantom Fiber Biofiber Suture | Tornier, Inc. | 2013 | — |
| +1 | K132348 | Tephaflex Braided Suture | Tepha, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 NWJ? 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 NWJ device
- #1 K211307 GalaSTITCH Absorbable Monofilament Suturescore 1.4 · 1 generation · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K122487 | Biofiber SytureSummary page 2…rnier BioFiber Suture To: Tornier Phantom Fiber (K122487) BioFiber Suture Indicati… | 2012 |
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 |
|---|---|---|---|
| K132348 | Tephaflex Braided Suture | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 8, 2018 | Class II | Z-1374-2018 | Nonconforming Material/Component | Data has shown that degradation of a raw material used in Phantom Fiber may occur more quickly than expected if improperly stored. This may impact the shelf-life of the product which could cause the suture to lose strength more quickly… |
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 5.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K132348 (Tepha, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122487.
How does its category compare?
All NWJ devicesNWJ Suture, Recombinant Technology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NWJ
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NWJ
Too few NWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NWJ
No recall names NWJ since 2007.
Adverse event reports per year · NWJ
4in 2025
MAUDE reports naming product code NWJ, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Phantom Fiber BioFiber Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130422: Phantom Fiber Biofiber Suture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130422
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