Search Results
Found 22 results
510(k) Data Aggregation
K Number
K233674Device Name
Freedom Wrist Arthroplasty System
Manufacturer
Ascension Orthopedics, Inc.
Date Cleared
2024-05-30
(196 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Applicant Name (Manufacturer) :
Ascension Orthopedics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Freedom Wrist Arthroplasty System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis of the radial/carpal joint and is intended to replace functionality of the joint due to deformity or elements stated above. The Freedom Wrist Arthroplasty System is intended for cemented use.
Device Description
The Freedom Wrist Arthroplasty System consists of components to replace the articulation of the distal radius and proximal row of carpal bones of the wrist joint. The components are intented together as a system, not individually as hemi-arthroplasty components. The radial component is made of Cobalt Chrome Molybenum Alloy (CrCoMo) and has a concave articulating surface and is fixed by means of a stem which is inserted into the radial intramedullary canal. The carpal implant is an assembly consisting of a titanium carpal plate, which is fixed into the carpal bones with a cemented central peg and locking caps. A convex Ultra-High-Molecular-Weight Polyethylene (UHMWPE) bearing is locked onto the carpal plate to articulate with the radial component.
Ask a Question
K Number
K233670Device Name
Ascension Silicone MCP; Ascension Silicone PIP
Manufacturer
Ascension Orthopedics, Inc.
Date Cleared
2023-12-14
(29 days)
Product Code
KYJ
Regulation Number
888.3230Why did this record match?
Applicant Name (Manufacturer) :
Ascension Orthopedics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ASCENSION Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
The ASCENSION Silicone MCP implant is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative or traumatic arthritis.
Device Description
The ASCENSION Silicone MCP and PIP implants are anatomically designed, single-use, one-piece, flexible hinge prostheses designed to be implanted without bone cement across the metacarpophalangeal (MCP) joint and proximal interphalangeal (PIP) joint. They are made from medical grade silicone elastomer. The proximal and distal stems of the prostheses are pre-flexed to match the approximate natural flexion position of the joint when the hand is relaxed. The MCP and PIP implants provide 90 degrees of flexion from full extension.
Ask a Question
K Number
K121826Device Name
INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Date Cleared
2013-02-13
(237 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ASCENSION ORTHOPEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Integra Proximal Humeral Fracture Plate System is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications include:
- Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures . involving osteopenic bone
- Pseudoarthroses in the proximal humerus .
- Osteotomies in the proximal humerus .
Device Description
The Integra Proximal Humeral Fracture Plate System is composed of left and right humeral reconstruction plate implants in two options, GT Plate and LP Plate. The GT plate is designed to cover the greater tuberosity and is available in four-hole , seven-hole, and ten-hole lengths or sizes. The LP plate is designed to sit lower on the greater tuberosity and is available in three-hole, six-hole, and nine-hole lengths or sizes. The system features 3.5mm locking, non-locking and lag screws, in addition to, 2.7mm locking screws. The Integra Proximal Humeral Fracture Plate System is a single component made from stainless steel (SS 316L). The non-locking, locking and lag screws are made from stainless steel (SS 316L).
Ask a Question
K Number
K110700Device Name
ASCENSION ATLAS HUMERAL PLATING SYSTEM
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Date Cleared
2011-12-06
(267 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ASCENSION ORTHOPEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ascension ATLAS® Humeral Fracture Plate system is designed for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus. Indications include:
- Dislocated two-, three-, and four-fragment fractures of the proximal humerus, including fractures involving osteopenic bone
- Pseudoarthroses in the proximal humerus
- Osteotomies in the proximal humerus
Device Description
The Ascension® ATLAS® Humeral Plate System will be composed of left and right humeral reconstruction plate implants in four-hole (HFP-0930-004LS, HFP-0930-004RS) and seven-hole (HFP-0930-007LS, HFP-0930-007RS) lengths or sizes. The system will also feature 3.5mm locking, non-locking and lag screws and 2.7mm locking and non-locking screws.
The ATLAS® Humeral Fracture Plate will be a single component made from stainless steel (SS 316L). The non-locking, locking and lag screws will be made from stainless steel (SS 316L).
Ask a Question
K Number
K102549Device Name
THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Date Cleared
2010-12-21
(105 days)
Product Code
LZJ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ASCENSION ORTHOPEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ascension® MOVEMENT™ Great Toe System, Total Arthroplasty is a twopiece implant that is intended to be used as prosthesis for the metatarsophalangeal joint (MTP). The device is intended for cemented use only. Indications for use include:
- Painful degenerative metatarso-phalangeal joint change .
- Hallux rigidus stage 3 and 4 ◆
- Hallux valgus and hallux rigidus .
- Hallux limitus with painful arthrofibrosis .
- Revisions after moderate proximal phalanx resection .
Device Description
The Ascension® MOVEMENT Great Toe System, Total Arthroplasty device is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device couples with the Ascension metatarsal hemi-arthroplasty device to allow total arthroplasty of the 1st MTP joint. The device is designed for cemented fixation. The device is boxed individually and delivered sterile for single use. The device incorporates four anatomically designed base geometries with appropriately sized stems. The stem is cylindrical with tapered ribs to provide rotational as well as axial stability of the seated implant. System instrumentation is designed to offer precise implant preparation.
Ask a Question
K Number
K100448Device Name
ASCENSION MODULAR TOTAL SHOULDER SYSTEM
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Date Cleared
2010-08-30
(194 days)
Product Code
KWS
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
ASCENSION ORTHOPEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for:
1. Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis.
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory.
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component).
Shoulder Hemiarthroplasty is also indicated for:
1. Ununited humeral head fractures.
2. Avascular necrosis of the humeral head.
3. Rotator cuff arthropathy.
4. Deformity and/or limited motion.
The humeral component is intended for cemented or un-cemented use. The glenoid component is intended for cemented use only.
Device Description
The Modular Total Shoulder System consists of a line of proximal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural numeral nead may befficient bearing surface, or in conjunction with the glenoid, as a gronold proximal bodies and humeral stems are manufactured from total replacemont: "The and connect together via a Morse type taper. The humeral theads are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and are offered in both concentric and eccentric configurations. The humeral head may onered in both contral glenoid bone if it is of sufficient quality, or against the all antionate against the naturanid. The glenoid is manufactured from ultra high polycthylone oomonton gronone (UHMVPE) and is offered in a keeled and pegged molecular weight porychylons (Ornaare designed to function with both the concentric and eccentric heads.
Ask a Question
K Number
K100502Device Name
ASCENSION TOTAL PLATE SYSTEM
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Date Cleared
2010-08-02
(161 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ASCENSION ORTHOPEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K100925Device Name
ASCENSION ANKLE FUSION NAIL SYSTEM
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Date Cleared
2010-07-12
(101 days)
Product Code
HSB
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
ASCENSION ORTHOPEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ascension® Ankle Fusion Nail System is intended for the following:
- . Charcot Foot
- Avascular necrosis of the talus .
- Failed total ankle arthroplasty .
- . Trauma (malunited tibial pilon fracture)
- Severe deformity or instability as a result of talipes equinovarus, cerebral vascular . accident, paralysis or other neuromuscular disease
- . Revision ankle arthrodesis
- . Neuroarthropathy
- . Rheumatoid arthritis
- Osteoarthritis .
- Pseudoarthrosis .
- Post-Traumatic arthrosis .
- Previously infected arthrosis .
- Severe end stage degenerative arthritis t
- Severe defects after tumor resection .
- Pantalar arthrodesis .
Device Description
The Ascension® Ankle Fusion Nail System is to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared for correction of deformity, or arthodesis.
The Ankle Fusion Nail System consists of nails, screws and an end cap. The standard nails are offered in three diameters and 3 lengths (150mm, 180mm and 210mm). Longer lengths up to 460mm will be made upon request. Fixation screws consist of one diameter and 27 lengths, and an end cap offered in one size. All three implant components will be manufactured from titanium 6AL-4V.
Ask a Question
K Number
K100176Device Name
ASCENSION ANKLE FUSION PLATE SYSTEM
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Date Cleared
2010-06-16
(146 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ASCENSION ORTHOPEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ascension Ankle Fusion Plate System is intended for the following:
- Arthrodesis of the ankle joint and distal tibia
- Fractures, osteotomies, fusions, and replantations of small bones in the foot and ankle.
Device Description
The Ascension® Ankle Fusion Plate System consists of two anterior tibia-talus and a lateral tibia-talus-calcaneus arthrodesis plates. The plates are contoured to the peri articular anatomy and have tapered threaded holes which accept compression or locking threaded screws with a maior thread diameter of 4.5 or 6.5mm. All plates and screws will be manufactured from stainless steel or titanium.
Ask a Question
K Number
K092047Device Name
ASCENSION METAL GREAT TOE SYSTEM
Manufacturer
ASCENSION ORTHOPEDICS, INC.
Date Cleared
2010-01-14
(192 days)
Product Code
KWD
Regulation Number
888.3730Why did this record match?
Applicant Name (Manufacturer) :
ASCENSION ORTHOPEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ascension® Metal Great Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The metatarsal and phalangeal components are used as hemi-arthroplasties as an uncemented joint treatment of patients with arthritis in the first metatarsal joint in the presence of good bone stock. Indications include:
- Hallux valgus or Hallux limitus
- Hallux rigidus
- Unstable or painful metatarsal/phalangeal (MTP) joint
Device Description
The Ascension® Metal Great Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 1st metatarsal head or the base of the proximal phalanx. The components are anatomically designed, monolithic devices designed for resurfacing of the head of the 1st metatarsal or the phalangeal (MTP) joint. The devices are made from cobalt chromium alloy with a commercially pure titanium plasma spray. These devices are intended as hemi-arthroplasties at either surface and are press-fit.
Each device is boxed individually and delivered sterile for single use.
Ask a Question
Page 1 of 3