(121 days)
The Synthes USS (including the Click'X®, USS VAS variable axis components, and Pangea™), Click'X® Monoaxial, Pangea 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, Pangea 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, Pangea Monoaxial and Dual-Opening USS Systems.
In addition, Synthes USS (including the Click'X®, USS VAS variable axis components, and Pangea™), Click'X® Monoaxial, Pangea Monoaxial and the Dual-Opening USS can be interchanged with all USS 6.0 mm rods and transconnectors.
The Pangea™ Monoaxial Screws and Hooks are similar to the cleared SYNTHES Click'X Monoaxial System (K031175). Both are components of the Universal Spinal System (USS). Pangea Monoaxial includes dual-core screws and a variety of hook profiles. The Synthes Pangea Monoaxial Screws and Hooks are fabricated from titanium alloy, conforming to ASTM F-1295.
The provided text is a 510(k) summary for the Synthes Pangea™ Monoaxial Screws and Hooks, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials with acceptance criteria typically found in PMA submissions or for AI/ML-driven devices.
Therefore, the document does NOT contain information regarding:
- Acceptance Criteria and Reported Device Performance in the form of a table.
- Sample sizes for test sets (as clinical or software performance testing, in the sense of AI/ML, is not the primary focus here).
- Data provenance or number of experts/qualifications for ground truth establishment.
- Adjudication methods.
- Multi Reader Multi Case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance studies.
- Type of ground truth used (pathology, outcomes data, etc., specific to AI/ML).
- Sample size for the training set or how ground truth for the training set was established.
Based on the provided text, the device meets regulatory requirements by demonstrating substantial equivalence to a predicate device.
Study that proves the device meets the acceptance criteria (Substantial Equivalence):
The submission demonstrates substantial equivalence to the predicate device, K031175 - SYNTHES Click'X Monoaxial System. The description highlights that the Pangea™ Monoaxial Screws and Hooks "are similar to the cleared SYNTHES Click'X Monoaxial System (K031175)" and are both components of the Universal Spinal System (USS).
The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This "finding of substantial equivalence" is the regulatory mechanism by which this device "meets the acceptance criteria" for market entry.
The supporting documentation for such a 510(k) would typically include:
- Mechanical Testing: To demonstrate that the Pangea™ Monoaxial Screws and Hooks meet similar mechanical performance standards (e.g., strength, fatigue, static and dynamic testing) as the predicate device, as per relevant ASTM or ISO standards for spinal fixation systems. While not explicitly detailed in the provided snippet, this is a standard expectation for such orthopedic devices.
- Material Equivalence: The document states the components are "fabricated from titanium alloy, conforming to ASTM F-1295," suggesting material equivalence to the predicate or other approved devices.
- Design Comparison: A detailed comparison of the design features (dual-core screws, hook profiles) to the predicate to establish that any differences do not raise new questions of safety or effectiveness.
Without access to the full 510(k) submission, specific performance data from these tests cannot be extracted or presented in a "table of acceptance criteria and reported device performance." The "acceptance criteria" in this context are primarily the regulatory requirements for demonstrating substantial equivalence to a predicate, which includes showing similar intended use, technological characteristics, and performance (often through non-clinical testing).
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510 (k) Summary
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
|---|---|
| 510 (k) Contact: | Angela MikroulisRegulatory Affairs Project ManagerPhone: (610) 719-5718Fax: (610) 719-5102 |
| Trade Name: | Synthes Pangea™ Monoaxial Screws and Hooks |
| Common / ClassificationName: | Spinal interlaminal fixation orthosis;Spinal intervertebral body fixation orthosis;Pedicle screw spinal system |
| Device Product Code andClassification: | KWP, KWQ, MNH, MNI and NKB21 CFR § 3050, 21 CFR § 3060, 21 CFR § 3070Class II and Class III |
| Predicate: | K031175- SYNTHES Click'X Monoaxial System |
| Device Description: | The Pangea™ Monoaxial Screws and Hooks are similar to thecleared SYNTHES Click'X Monoaxial System (K031175). Bothare components of the Universal Spinal System (USS).Pangea Monoaxial includes dual-core screws and a variety of hookprofiles.The Synthes Pangea Monoaxial Screws and Hooks are fabricatedfrom titanium alloy, conforming to ASTM F-1295. |
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| Intended Use/ Indicationsfor Use: | The Synthes USS (including the Click'X®, USS VAS variable axiscomponents, and Pangea™), Click'X® Monoaxial, PangeaMonoaxial, Dual-Opening and the Small Stature USS (whichincludes small stature and pediatric patients) are non-cervical spinalfixation devices intended for use as posterior pedicle screw fixationsystems (T1-S2), a posterior hook fixation system (T1-L5), or as aanterolateral fixation system (T8-L5). Pedicle screw fixation islimited to skeletally mature patients with the exception of the SmallStature USS. These devices are indicated for all of the followingindications regardless of the intended use: degenerative disc disease(defined as discogenic back pain with degeneration of the discconfirmed 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 posteriorpedicle screw construct.When used with the 3.5/6.0 mm parallel connectors, the SynthesUSS (including the Click'X®, USS VAS variable axis components,and Pangea™), Click'X® Monoaxial, Pangea 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 SmallStature USS can be linked to the Synthes USS (including theClick'X®, USS VAS variable axis components, and Pangea™), theClick'X® Monoaxial, Pangea Monoaxial and Dual-Opening USSSystems.In addition, Synthes USS (including the Click'X®, USS VASvariable axis components, and Pangea™), Click'X® Monoaxial,Pangea Monoaxial and the Dual-Opening USS can be interchangedwith all USS 6.0 mm rods and transconnectors. |
|---|---|
| --------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings forming a protective shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
APR - 5 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Angela Mikroulis Regulatory Affairs Project Manager Synthes Spine 1302 Wrights Lane East West Chester, PA 19380
Re: K052151
Trade Name: Pangea™ Monoaxial Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, MNH, MNI, KWO, KWP Dated: December 1, 2005 Received: December 2, 2005
Dear Ms. Mikroulis:
This letter corrects our substantially equivalent letter of December 7, 2005.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 M. Milliken
Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K052151
Device Name: Synthes Pangea Monoaxial System
Indications for Use:
The Synthes USS (including the Click' X®, USS VAS variable axis components, and Pangea™), Click'X® Monoaxial, Pangea 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 an 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, Pangea 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 CerviFix System. When used with the 5.0/6.0mm 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, Pangea Monoaxial, and Dual Opening USS Systems.
In addition. Synthes USS (including the Click'X, USS VAS variable axis components, and Pangea), Click'X Moroaxial, Pangea Monoaxial and the Dual Opening USS can be interchanged with all USS 6.0mm 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 OF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, Neurological Devices
| 510(k) Number | K052151 |
|---|---|
| --------------- | --------- |
9/66
N/A