# Xiros, Ltd.

- Location (FDA's records): Leeds, GB
- FDA decisions: 12 (2001–2025): 12 510(k) clearances
- Names in FDA's records: Xiros, Ltd. (9); Xiros Plc (2); Xiros Limited (1)
- Product codes: FTL (3), GAT (2), QUW (2), MBI (2), HTN (1), HTY (1), JDR (1)
- 510(k) review time since 2016: median 89 days, against 90 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 14 (4 its own); citations of its devices by later devices: 10 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- International Life Sciences: 2 (https://510kreport.com/company/international-life-sciences)
- Arthrex, Inc.: 2 (https://510kreport.com/company/arthrex)
- Synovis Orthopedic and Woundcare, Inc.: 1 (https://510kreport.com/company/synovis-orthopedic-and-woundcare)
- Xylos Corporation: 1 (https://510kreport.com/company/xylos)
- Fibralign Corporation: 1 (https://510kreport.com/company/fibralign)
- Surgicraft, Ltd.: 1 (https://510kreport.com/company/surgicraft)
- Biomerix Corporation: 1 (https://510kreport.com/company/biomerix)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Firms that cite its devices most
- Theramicro: 4 (https://510kreport.com/company/theramicro)
- Fournitures Hospitalieres Industrie: 1 (https://510kreport.com/company/fournitures-hospitalieres-industrie)
- ZuriMED Technologies AG: 1 (https://510kreport.com/company/zurimed-technologies)

## Its most-cited devices
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), cited by 3
- K222978: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), cited by 3
- K002172: Poly-Tapes (Various Sizes and Woven Construction Variants) (2001), cited by 2
- K211563: Pitch-Patchs (2021), cited by 1
- K151601: Secure-Loop (2015), cited by 1

## Recent decisions
- K242237: Jewel Soft Tissue Reinforcement Device (102-6005) (Jul 15, 2025)
- K230671: Pitch PaSoft Tissue Reinforcement Device (May 31, 2023)
- K222978: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (Dec 27, 2022)
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (Aug 26, 2022)
- K220906: Secure-Lock (Jul 22, 2022)
- K211563: Pitch-Patchs (Aug 13, 2021)
- K191053: Xtreme-Loop (Jul 17, 2019)
- K180243: Infinity-Lock Button System (Apr 3, 2018)

Source page: https://510kreport.com/company/xiros