510(k) · Cleared
ClearedFiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
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 Dec 11, 2024 as substantially equivalent to K211563 (Xiros, Ltd., 2021) after a 224-day review. Its family tree reaches back 11 generations to 1992. 1 later device descends from it.
- Decided
- Dec 11, 2024
- Review
- 224 days
- Class
- Class II
- Product code
- OWX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K921895 (1992). 52 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations between
- 3 generations backK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- 2 generations backK072370 Surgicraft Surgical Mesh SystemSurgicraft, Ltd. · 2008
- 1 generation backK211563 Pitch-PatchsXiros, Ltd. · 2021
- This deviceK241219 FiberLocker System: FiberLocker Implant (SpeedPatch PET)…ZuriMED Technologies AG · 2024
- Descendant · cites it directly · 0 of its ownK253867 FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG · 2026
Show all 11 generations
- Root · 11 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 10 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 9 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 8 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 7 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 6 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 5 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 4 generations backK052830 SportmeshArtimplant AB · 2006
- 3 generations backK070961 Biomerix Surgical Mesh, Model: RCR-01Biomerix Corporation · 2008
- 2 generations backK072370 Surgicraft Surgical Mesh SystemSurgicraft, Ltd. · 2008
- 1 generation backK211563 Pitch-PatchsXiros, Ltd. · 2021
- This deviceK241219 FiberLocker System: FiberLocker Implant (SpeedPatch PET)…ZuriMED Technologies AG · 2024
Most influential descendants
Showing 1 of 1 · See all- K253867FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnitZuriMED Technologies AG · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −10 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −9 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −8 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −7 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −6 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −5 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −4 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| −3 | K070961 | Biomerix Surgical Mesh, Model: RCR-01 | Biomerix Corporation | 2008 | — |
| −2 | K072370 | Surgicraft Surgical Mesh System | Surgicraft, Ltd. | 2008 | — |
| −1 | K211563 | Pitch-Patchs | Xiros, Ltd. | 2021 | — |
| 0 (this device) | K241219 | FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker… | ZuriMED Technologies AG | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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 K253867 FiberLocker Implant ; FiberLocker Instrument…score 13.9 · 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? (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 |
|---|---|---|---|
| * | K211563 | Pitch-PatchsSummary page 5…em described in this submission is substantially equivalent to the following predicate device: Primary Predicate: Pitch-Patch Tissue Reinforcement Device (K211563) Reference Devices: Rotation Medical, Inc. Collagen Tendon Sheet-Ddi (K140300) Rotation Medical, Inc. Rota… | 2021 |
| † | K140300 | Collagen Tendon Sheet-Ddi (CTS-Ddi) | 2014 |
| † | K131637 | Rotation Medical Soft Tissue Staple (RMST Staple) | 2013 |
| † | K160176 | Signia Stapler | 2016 |
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 |
|---|---|---|---|
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit | 2026 | 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 32 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 52 ancestors have a recall of any class.
- Of its descendants, K253867 (ZuriMED Technologies AG, 2026) has gone furthest, with 0 descendants of its own.
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. 2024, 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/K241219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241219: FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241219
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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