(49 days)
The Synthes USS (including the Click'X®, and USS VAS variable axis components, and Pangea™), Click'X® Monoaxial, Dual-Opening and the Small Stature USS (which includes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5/6.0 mm parallel connectors, the Synthes USS (including the Click'X® and, USS VAS variable axis components, and Pangea™), Click'X® Monoaxial and Dual-Opening USS can be linked to the CerviFix® System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including the Click'X®, and USS VAS variable axis components, and Pangea™), the Click' X® Monoaxial and Dual-Opening USS Systems.
In addition, Synthes USS (including the Click'X®, and USS VAS variable axis components, and Pangea™), Click'X® Monoaxial and the Dual-Opening USS can be interchanged with all USS 6.0 mm rods and transconnectors
The PangeaTM System is similar to the cleared Click'X (K992739). Both are components of the Universal Spinal System (USS).
The Pangea System includes polyaxial dual-core screws and a non threaded quarter turn in design locking cap.
The Synthes Pangea polyaxial screws and locking cap are fabricated from commercially pure titanium and titanium alloy, conforming to ASTM F67 and ASTM F-1295 respectively.
This document is a 510(k) summary for the Pangea™ System, a spinal fixation device. It describes the device, its intended use, and its classification, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The provided text focuses on:
- Device Identification: Firm name, contact, trade name, common name, product codes, classification, and predicate device.
- Device Description: What the Pangea™ System is comprised of (polyaxial dual-core screws, non-threaded quarter-turn locking cap) and the materials used.
- Intended Use/Indications for Use: A detailed list of conditions and anatomical locations for which the device is intended (e.g., degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, pseudoarthrosis, failed previous fusion), and some limitations (e.g., pedicle screw fixation limited to skeletally mature patients, restrictions on transverse bars for DDD, interoperability with other systems).
- FDA Clearance Letter: Confirmation from the FDA that the device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based solely on the provided text. The requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study details, standalone performance, and training set information) is entirely absent from this 510(k) summary.
In summary, the provided content is a regulatory submission for device clearance, not a performance study report.
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510(k) Summary
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
|---|---|
| 510(k) Contact: | Angela MikroulisSpine Regulatory Affairs SpecialistTelephone: 610-719-5718Facsimile: 610-719-5102 |
| Trade Name: | PangeaTMSystem |
| Common Name/Classification Name: | Spinal interlaminal fixation orthosis;Spinal intervertebral body fixation orthosis;Pedicle screw spinal system |
| Device ProductCode andClassification: | KWP, KWQ, MNH, MNI, NKB21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070CLASS II and Class III |
| Predicate: | Click'X (K992739) |
| Device Description: | The PangeaTM System is similar to the cleared Click'X (K992739). Both arecomponents of the Universal Spinal System (USS).The Pangea System includes polyaxial dual-core screws and a non threadedquarter turn in design locking cap.The Synthes Pangea polyaxial screws and locking cap are fabricated fromcommercially pure titanium and titanium alloy, conforming to ASTM F67and ASTM F-1295 respectively. |
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| Intended Use /Indications for Use: | The Synthes USS (including the Click'X®, and USS VAS variable axiscomponents, and Pangea™), Click'X® Monoaxial, Dual-Opening and theSmall Stature USS (which includes small stature and pediatric patients) arenon-cervical spinal fixation devices intended for use as posterior pediclescrew fixation systems (T1-S2), a posterior hook fixation system (T1-L5), oras a anterolateral fixation system (T8-L5). Pedicle screw fixation is limitedto skeletally mature patients with the exception of the Small Stature USS.These devices are indicated for all of the following indications regardless ofthe intended use: degenerative disc disease (defined as discogenic back painwith degeneration of the disc confirmed by history and radiographic studies),spondylolisthesis, trauma (i.e., fracture or dislocation), deformities orcurvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann'sDisease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.When treating patients with Degenerative Disc Disease (DDD), transversebars are not cleared for use as part of the posterior pedicle screw construct.When used with the 3.5/6.0 mm parallel connectors, the Synthes USS(including the Click'X® and, USS VAS variable axis components, andPangea™), Click'X® Monoaxial and Dual-Opening USS can be linked tothe CerviFix® System. In addition, when used with 3.5/5.0 mm parallelconnectors, the Synthes Small Stature USS can be linked to the Synthes USS(including the Click'X®, and USS VAS variable axis components, andPangea™), the Click' X® Monoaxial and Dual-Opening USS Systems.In addition, Synthes USS (including the Click'X®, and USS VAS variableaxis components, and Pangea™), Click'X® Monoaxial and the Dual-Opening USS can be interchanged with all USS 6.0 mm rods andtransconnectors |
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Page 2 - Ms. Angela Mikroulis
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K052123 510(k) Number:
Pangea TM Device Name:
The Synthes USS (including the Click'X®, USS VAS variable axis Indications for use: components, and Pangea™), Click'X® Monoaxial, Dual-Opening and the Small Stature USS (which includes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5/6.0 mm parallel connectors, the Synthes USS (including the Click' X®, USS VAS variable axis components, and Pangea™), Click'X® Monoaxial and Dual-Opening USS can be linked to the CerviFix® System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including the Click' X®, USS VAS variable axis components, and Pangea™), the Click'X® Monoaxial and Dual-Opening USS Systems.
In addition. Synthes USS (including the Click'X®, USS VAS variable axis components, and Pangea™), Click' X® Monoaxial and the Dual-Opening USS can be interchanged with all USS 6.0 mm rods and transconnectors.
| Prescription Use | X (Part 21 CFR 801 Subpart D) |
|---|---|
| AND/OR | |
| Over-The-Counter Use | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number K052123
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.