510(k) · Cleared
ClearedFiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ZuriMED Technologies AG · OWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
Cleared on Jan 2, 2026 as substantially equivalent to K241219 (ZuriMED Technologies AG, 2024) after a 30-day review. Its family tree reaches back 12 generations to 1992.
- Decided
- Jan 2, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- OWX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K921895 (1992). 53 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 12 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 8 generations between
- 3 generations backK072370 Surgicraft Surgical Mesh SystemSurgicraft, Ltd. · 2008
- 2 generations backK211563 Pitch-PatchsXiros, Ltd. · 2021
- 1 generation backK241219 FiberLocker System: FiberLocker Implant (SpeedPatch PET)…ZuriMED Technologies AG · 2024
- This deviceK253867 FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG · 2026
Show all 12 generations
- Root · 12 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 11 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 10 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 9 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 8 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 7 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 6 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 5 generations backK052830 SportmeshArtimplant AB · 2006
- 4 generations backK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- 3 generations backK072370 Surgicraft Surgical Mesh SystemSurgicraft, Ltd. · 2008
- 2 generations backK211563 Pitch-PatchsXiros, Ltd. · 2021
- 1 generation backK241219 FiberLocker System: FiberLocker Implant (SpeedPatch PET)…ZuriMED Technologies AG · 2024
- This deviceK253867 FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −11 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −10 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −9 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −8 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −7 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −6 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −5 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| −4 | K070961 | Biomerix Surgical Mesh, Model: RCR-01 | Biomerix Corporation | 2008 | — |
| −3 | K072370 | Surgicraft Surgical Mesh System | Surgicraft, Ltd. | 2008 | — |
| −2 | K211563 | Pitch-Patchs | Xiros, Ltd. | 2021 | — |
| −1 | K241219 | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker… | ZuriMED Technologies AG | 2024 | — |
| 0 (this device) | K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | ZuriMED Technologies AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 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 OWX? 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 OWX device
- #1 K241219 FiberLocker System: FiberLocker Implant…score 14.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K241219 | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument…Summary page 5…device: • Primary Predicate: FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) (K241219) Device Description The FiberLocker System is comprised of two components: (1) the FiberLocker Implant (SpeedPatc… | 2024 |
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 34 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 53 ancestors have a recall of any class.
How does its category compare?
All OWX devicesOWX Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OWX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWX
Too few OWX 510(k)s in any year since 2007 to give a median.
Recalls per year · OWX
No recall names OWX since 2007.
Adverse event reports per year · OWX
2in 2025
MAUDE reports naming product code OWX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 2 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Fiberlocker® System is a single-use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue.
The Fiberlocker® System is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253867: FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253867
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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