(121 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a spinal fixation system indicated for treating various medical conditions such as degenerative disc disease, trauma, deformities, and tumors, which are all therapeutic interventions.
No
Explanation: The document describes the device as a "spinal fixation device" and outlines its use as a "posterior pedicle screw fixation system," "posterior hook fixation system," or "anterolateral fixation system." These are all interventional or treatment-related functions, not diagnostic ones. The indications for use describe conditions the device is used to treat, not to identify or diagnose.
No
The device description explicitly states that the device components are fabricated from titanium alloy, indicating a physical hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fixation. This involves physically stabilizing the spine.
- Device Description: The device description details components like screws and hooks made from titanium alloy, which are typical for surgical implants.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are used in vitro (outside the body) to diagnose or monitor conditions.
This device is a surgical implant used in vivo (inside the body).
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
KWP, KWQ, MNH, MNI and NKB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal, posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5)
Indicated Patient Age Range
skeletally mature patients with the exception of the Small Stature USS (which includes small stature and pediatric patients)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K031175- SYNTHES Click'X Monoaxial System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
510 (k) Summary
| Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Contact: | Angela Mikroulis
Regulatory Affairs Project Manager
Phone: (610) 719-5718
Fax: (610) 719-5102 |
| Trade Name: | Synthes Pangea™ Monoaxial Screws and Hooks |
| Common / Classification
Name: | Spinal interlaminal fixation orthosis;
Spinal intervertebral body fixation orthosis;
Pedicle screw spinal system |
| Device Product Code and
Classification: | KWP, KWQ, MNH, MNI and NKB
21 CFR § 3050, 21 CFR § 3060, 21 CFR § 3070
Class II and Class III |
| Predicate: | K031175- SYNTHES Click'X Monoaxial System |
| Device Description: | 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. |
1
| Intended Use/ 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 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. |
| --------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
2
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.
3
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
4
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 |
|---|---|
| --------------- | --------- |
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