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510(k) Data Aggregation
K Number
K030259Device Name
AMATOMICAL SHOULDER WITH REMOVABLE HEAD
Manufacturer
CENTERPLUS ORTHOPEDICS, INC
Date Cleared
2003-04-24
(90 days)
Product Code
KWS
Regulation Number
888.3660Why did this record match?
Applicant Name (Manufacturer) :
CENTERPLUS ORTHOPEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Centerpulse Orthopedics Anatomical Shoulder™ System with Removable Head is intended for use in treatment of the following:
1. Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
2. Omarthrosis.
3. Rheumatoid arthritis.
4. Revision of shoulder prosthesis.
5. Traumatology: the only cone to be used in traumatological indications is the traumatology cone.
Device Description
The system consists of the following:
- Humeral stem, uncemented .
- Humeral stem, cemented ●
- Humeral stem, revision, cemented ●
- Ball-cone with taper .
- Glenoid .
- Humeral head .
The Anatomical Shoulder™ System with Removable Head was designed to enable the surgeon to remove the head, including the sphere connection, from the stem at any time. This is possible due to the introduction of an oval cone connection. The head is removable in order to gain access to the glenoid or to select other types of humeral heads.
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K Number
K023528Device Name
NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
Manufacturer
CENTERPLUS ORTHOPEDICS, INC
Date Cleared
2003-01-17
(88 days)
Product Code
JWH
Regulation Number
888.3560Why did this record match?
Applicant Name (Manufacturer) :
CENTERPLUS ORTHOPEDICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Natural-Knee II Cemented Modular Tibial Baseplate is intended for cemented use only in total knee arthroplasty for treatment of the following conditions:
1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
2. Correctable valgus-varus deformity and moderate flexion contracture.
3. Those patients with failed previous surgery where pain, deformity or dysfunction persists.
Device Description
The Natural-Knee II Cemented Tibial Baseplate is an asymmetrically oriented (e.g. both left and right orientations), nonporous component manufactured from cast CoCr alloy (ASTM F75).
The baseplate is designed to mate with all previously cleared tibial insert components of the Natural-Knee/Natural-Knee II System via capture features on the anterior rim and posterior plateau rims. As such, the baseplate incorporates the snap lock design from the previously cleared Natural-Knee II tibial baseplates. A slot has also been incorporated into the center of the base of the tray to allow for seating of the metal reinforcement pin of the previously cleared Natural-Knee II Constrained/Revision tibial inserts.
The cruciform stem portion of the baseplate is designed to accept one of the previously cleared stems used with the Natural-Knee II System (smooth straight, fluted straight, fluted offset). The baseplate stem boss incorporates the stem connection design of the previously cleared Natural-Knee II Revision Femoral Component. This connection design includes an inner female taper for primary attachment of the stem. Supplemental secondary stem fixation may be achieved by placing the stem attachment screw through the recessed hole in the baseplate and into the screw hole in the stem. The rounded, baseplate stem hole plug designed for use with this component may also be used if a stem is not desired. Unlike the stems, the plug does not possess a taper and is attached to the baseplate solely via the stem attachment screw previously described.
The inferior surface of the baseplate has cement pockets that are grit blasted to enhance cement fixation. The three fins of the stem boss aid in maintaining rotational stability.
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