(49 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
Explanation: This device is described as a "spinal fixation device" and is intended for use in treating various medical conditions such as degenerative disc disease, spondylolisthesis, trauma, deformities, tumor, stenosis, pseudoarthrosis, and failed previous fusion. These uses cases clearly indicate that its purpose is to alleviate or treat a disease, injury, or condition, which aligns with the definition of a therapeutic device.
No
The device is described as a non-cervical spinal fixation device, intended for surgical implantation to provide stability to the spine, not for diagnosing conditions.
No
The device description explicitly states that the device includes physical components such as screws and locking caps fabricated from titanium, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a "non-cervical spinal fixation device" used for surgical implantation to stabilize the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and components of a spinal implant (screws, rods, locking caps). This aligns with a surgical device, not a device used to test samples from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
Therefore, this device falls under the category of a surgical implant or fixation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
KWP, KWQ, MNH, MNI, NKB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal fixation devices, T1-S2, T1-L5, T8-L5
Indicated Patient Age Range
skeletally mature patients with the exception of the Small Stature USS, pediatric patients (Small Stature USS)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Click'X (K992739)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary
| Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Angela Mikroulis
Spine Regulatory Affairs Specialist
Telephone: 610-719-5718
Facsimile: 610-719-5102 |
| Trade Name: | PangeaTMSystem |
| Common Name/
Classification Name: | Spinal interlaminal fixation orthosis;
Spinal intervertebral body fixation orthosis;
Pedicle screw spinal system |
| Device Product
Code and
Classification: | KWP, KWQ, MNH, MNI, NKB
21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070
CLASS II and Class III |
| Predicate: | Click'X (K992739) |
| Device Description: | 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. |
1
| Intended Use /
Indications for Use: | 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 |
| ---------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
2
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
3
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