(85 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural components of a pedicle screw system, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a pedicle screw system intended for immobilization and stabilization of spinal segments, and explicitly states it is an "adjunct to fusion." These are direct therapeutic interventions.
No
The F1 MPS Modular Pedicle Screw System is a surgical implant designed for stabilization and immobilization of spinal segments, not for diagnosis.
No
The device description clearly states it is a modular system composed of cannulated and non-cannulated pedicle screws, rods, and connectors, which are physical hardware components.
Based on the provided text, the F1 MPS Modular Pedicle Screw System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for spinal fixation and stabilization. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, and connectors made of titanium and cobalt-chromium-molybdenum. These are materials used for implants, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, the F1 MPS Modular Pedicle Screw System falls under the category of a surgical implant or spinal fixation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The F1 MPS Modular Pedicle Screw System (F1 MPS) is intended for posterior, non-cervical pedicle fixation (T1-S1) 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 thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment; Severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; Fracture; Dislocation; Spinal stenosis; Scoliosis or kyphotic deformities; Spinal Tumor; Schuermann's disease; Failed previous fusion.
The F1 MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.
The F1 MPS is also intended to stabilize the posterior non-cervical fixation in pediatric patients indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI, OSH
Device Description
The F1 MPS system is modular system composed of cannulated and non-cannulated pedicle screws of various lengths and diameters which are designed to accept a 5.5mm rod in various lengths. The components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient.
This submission addresses the line extension of CONNECT-L Transverse Connector and JOUST minimally invasive rods to the F1 MPS Modular Pedicle Screw System (K142531), and make FDA aware of minor changes to F1 MPS for manufacturability.
The CONNECT-L Transverse Connector comes in fixed and variable sizes. The JOUST™ minimally invasive rods are used in a minimally invasive approach. The JOUST™ minimally invasive manual surgical instruments aid in percutaneous approach. Additional 5.5mm rods are added to this system to allow for ease of entry.
The F1 MPS system is provided non-sterile. The system is constructed from Titanium and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 and/or cobalt-chromium-molybdenum per ASTM F1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical pedicle fixation (T1-S1)
Indicated Patient Age Range
skeletally mature patients, pediatric patients (for adolescent idiopathic scoliosis)
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)
Non-clinical testing was performed to demonstrate the addition of the subject components to the already cleared DeGen Medical F1 MPS is substantially equivalent to other predicate devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. The following tests were performed:
Static and dynamic compression testing per ASTM F1717 Static Torsional Gripping Capacity testing per ASTM F1798 The results of these studies show the subject devices meets or exceeds the performance of the predicate devices, and the device was therefore found to be substantially equivalent.
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.
K142531, K061520, K071860, K062196, K933881, K953915, K982320, K982511, K982011, K983583, K992168, K011182, K030383
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem consists of four stylized human profiles facing to the right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 28, 2016
DeGen Medical % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188
Re: K160926
Trade/Device Name: F1 MPS Modular Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, OSH Dated: April 25, 2016 Received: April 26, 2016
Dear Dr. Braddon:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Linda Braddon, Ph.D.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K160926
Device Name
F1 MPS Modular Pedicle Screw System
Indications for Use (Describe)
The F1 MPS Modular Pedicle Screw System (F1 MPS) is intended for posterior, non-cervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment; Severe spondy|olisthesis (grades 3 and 4) of the L5-S1 vertebra; Fracture; Dislocation; Spinal stenosis; Scoliosis or kyphotic deformities; Spinal Tumor; Schuermann's disease; Failed previous fusion.
The F1 MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.
The F1 MPS is also intended to stabilize the posterior non-cervical fixation indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft.
Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/0 description: The image contains the logo for DeGen Medical. The logo consists of a blue abstract design on the left and the company name on the right. The abstract design features three curved lines with circles at the end, resembling a stylized network or connection symbol. The text "DeGen" is in a larger, bolder blue font, while "Medical" is in a smaller, gray font below it.
510(k) Summary of Safety and Effectiveness
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the DeGen Medical F1 MPS Modular Pedicle Screw System with the addition of the Connect-L Transverse Connector and JOUST™ minimally invasive rods line extensions is provided below.
| Date Summary
| Prepared | June 14, 2016 |
|---|---|
| Sponsor | DeGen Medical |
| 1321-C North Cashua Drive | |
| Florence, SC 29501 | |
| Phone 877-240-7838 | |
| Fax 843-407-0545 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| LGB@SecureBME.com | |
| Trade Name | F1 MPS Modular Pedicle Screw System |
| Common Name | Pedicle screw spinal system |
| Code - | |
| Classification | NKB 21 CFR 888.3070 : Class III |
| MNH, MNI, OSH 21 CFR 888.3070 : Class II | |
| Primary Predicate | |
| Device | K142531 DeGen Medical F1 MPS Modular Pedicle Screw System |
| Additional | |
| Predicates | K061520, K071860 DePuy Spine Viper Spine System |
| K062196 DePuy Spine SFX Snap-Fit Cross Connector | |
| K933881, K953915, K982320, K982511, K982011, K983583, K992168, K011182, | |
| K030383 DePuy Moss Miami Spinal System | |
| Device | |
| Description | The F1 MPS system is modular system composed of cannulated and non-cannulated pedicle screws of various lengths and diameters which are designed to accept a 5.5mm rod in various lengths. The components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. |
This submission addresses the line extension of CONNECT-L Transverse Connector and JOUST minimally invasive rods to the F1 MPS Modular Pedicle Screw System (K142531), and make FDA aware of minor changes to F1 MPS for manufacturability.
The CONNECT-L Transverse Connector comes in fixed and variable sizes. The JOUST™ minimally invasive rods are used in a minimally invasive approach. The JOUST™ minimally invasive manual surgical instruments aid in percutaneous approach. Additional 5.5mm rods are added to this system to allow for ease of entry.
The F1 MPS system is provided non-sterile. The system is constructed from Titanium and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 and/or cobalt-chromium-molybdenum per ASTM F1537. |
| Indications for
Use | The F1 MPS Modular Pedicle Screw System (F1 MPS) is intended for posterior, non-cervical pedicle fixation (T1-S1) 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 thoracic, lumbar, and sacral spine: Degenerative spondylolisthesis with objective evidence of neurological impairment; Severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; Fracture; Dislocation; Spinal stenosis; Scoliosis or kyphotic deformities; Spinal Tumor; Schuermann's disease; Failed previous fusion.
The F1 MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.
The F1 MPS is also intended to stabilize the posterior non-cervical fixation in pediatric patients indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft. |
| Technological
Characteristics | As was established in this submission, both additions and minor changes to the
F1 MPS are substantially equivalent to other predicate devices cleared by the
FDA for commercial distribution in the United States. The subject devices were
shown to be substantially equivalent and has the same technological
characteristics to its predicate devices through comparison in areas including
design, intended use, material composition, function, and range of sizes. |
| Non-Clinical
Performance
Testing
Conclusion | Non-clinical testing was performed to demonstrate the addition of the subject
components to the already cleared DeGen Medical F1 MPS is substantially
equivalent to other predicate devices in accordance with "Guidance for Industry
and FDA Staff, Guidance for Spinal System 510(k)s", May 3, 2004. The following
tests were performed:
Static and dynamic compression testing per ASTM F1717 Static Torsional Gripping Capacity testing per ASTM F1798 The results of these studies show the subject devices meets or exceeds the
performance of the predicate devices, and the device was therefore found to be
substantially equivalent. |
| Substantial
Equivalence
Summary
(Conclusion) | The subject DeGen Medical F1 MPS System and components, CONNECT-L
Transverse Connector and the JOUST™ minimally invasive rods, have been shown
to be substantially equivalent to legally marketed predicate devices. |
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Image /page/5/Picture/0 description: The image contains the logo for DeGen Medical. The logo consists of a stylized graphic on the left and the company name on the right. The graphic features three curved lines emanating from three circles, creating a sense of movement and connection. The text "DeGen" is in a larger, bolder font, while "Medical" is in a smaller, lighter font below it.
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Image /page/6/Picture/0 description: The image contains the logo for DeGen Medical. The logo consists of a stylized graphic on the left and the text "DeGen Medical" on the right. The graphic features three curved lines emanating from three circles, all in shades of blue. The text "DeGen" is in a larger, bolder blue font, while "Medical" is in a smaller, gray font.