Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007319107

FEI Number

3007319107

Entity Name

PARCUS MEDICAL , L.L.C.

City/State/Country

Sarasota, FL, US

Establishment Address

6423 Parkland Dr, Sarasota, FL 34243, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medacta International SA (Owner Number: 10024526)

Owner / Operator Contact Address

Strada Regina, Castel San Pietro, CH-TI 6874, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111000

PMA Number

N/A

All Registered Proprietary Names

Twist AP Suture Anchors TWIST PEEK SUTURE ANCHOR Synd-EZ SS Synd-EZ SS Synd-EZ Ti V-LOX TITANIUM SUTURE ANCHOR PEEK CF PUSH-IN SUTURE ANCHORS Arthroscopic Instruments GFS SLiK Fix Screw Awl PPEK CF INTERFERENCE SCREW V-LOX PEEK CF SUTURE ANCHOR Drill Bit AcTiFlip , GFS Ultimate Hip Surgical Instrument Fastener, Fixation, Nondegradable, Soft Tissue Screwdriver GRAFT FIXATION SYSTEM Bone screw starter GFS Ultimate GFS Titanium Interference Screw Titanium Interference Screws SLiK Anchors GFS BTB Traction Instrument Bone Tap V-lox Titanium Suture Anchors and Miti Suture Anchors X-Twist Biocomposite Suture Anchor PEEK CF PUSH-IN SUTURE ANCHOR DRAW TIGHT 1.8MM SINGLE-LOADED SUTURE ANCHOR PEEK CF PUSH-IN SUTURE ANCHOR Knotless AP Suture Anchors MITI TITANIUM SUTURE ANCHOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-11
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2018-12-05
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
HWJ	Awl	Orthopedic	Class 1	888.4540	2025-06-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2025-06-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2023-01-05
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2023-01-05
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2025-06-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2025-06-12
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2025-06-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-06-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2025-06-11
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-11
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-06-11

Official Correspondent

Stefano Baj

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medacta International SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005180920	MEDACTA INTERNATIONAL SA	Castel San Pietro Ticino, CH
3008110533	MEDACTA INTERNATIONAL SA	Rancate Ticino, CH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K203334	Acuitive Technologies, Inc.	The Citrefix Knotless Suture Anchor	2021-02-05
K243467	Osteonic Co., Ltd.	Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)	2024-12-03
K213415	OSSIO , Ltd.	OSSIOfiber Suture Anchor	2022-03-28
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007319107. Last updated year: 2026. Please use registration number 3007319107 when referencing this establishment in official correspondence.