Xiros, Ltd.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Xiros, Ltd.” (first 2015, latest 2023), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 89 days. Since 2017 the median was 87 days, against 86 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 89 |
| 2016 | 0 | — |
| 2017 | 1 | 24 |
| 2018 | 1 | 64 |
| 2019 | 1 | 89 |
| 2020 | 0 | — |
| 2021 | 1 | 85 |
| 2022 | 3 | 115 |
| 2023 | 1 | 82 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Xiros, Ltd. took a median 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 86 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 3 | 3 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| HTN | Washer, Bolt Nut | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| QUW | Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament | 1 | 1 |
Review panels
Most recent Xiros, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230671 | Pitch PaSoft Tissue Reinforcement Device | FTL | 2023-05-31 | 82 |
| K222978 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | QUW | 2022-12-27 | 90 |
| K220091 | Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device | FTL | 2022-08-26 | 226 |
| K220906 | SECURE-LOCK | HTY | 2022-07-22 | 115 |
| K211563 | Pitch-Patchs | FTL | 2021-08-13 | 85 |
| K191053 | Xtreme-Loop | MBI | 2019-07-17 | 89 |
| K180243 | Infinity-Lock Button System | HTN | 2018-04-03 | 64 |
| K171680 | Infinity-Lock 3, Infinity-Lock 5 | GAT | 2017-06-30 | 24 |
| K151601 | SECURE-LOOP | MBI | 2015-09-09 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Xiros, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Xiros, Ltd. is the lead sponsor of 5 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT05906004: Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff (Recruiting, started 2026-05)
- NCT05397210: Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation (Recruiting, started 2022-09-26)
- NCT05264389: Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction (Active not recruiting, started 2022-09-05)
- NCT05304819: PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair (Completed, started 2022-03-09)
- NCT04580290: Jewel ACL Post Market Clinical Follow Up Study (Completed, started 2020-10-02)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Xiros Plc (2 510(k)s)
- Xiros Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Xiros, Ltd.?
FDA lists 9 510(k) clearances under the applicant name “Xiros, Ltd.” (first 2015, latest 2023), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Xiros, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Xiros, Ltd. is 89 days. Since 2017: 87 days, versus 86 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Xiros, Ltd.?
The most frequent FDA product codes under this applicant name are FTL (Mesh, Surgical, Polymeric, 3); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 2); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 1).
Next steps
- See all 9 Xiros, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FTL, Xiros, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.