(113 days)
No
The summary describes a mechanical spinal fixation system with no mention of software, image processing, or AI/ML terms.
Yes
The device is described as a "posterior spinal fixation system" intended for "immobilization and stabilization of spinal levels as an adjunct to fusion" in patients with various spinal conditions, which directly aligns with the definition of a therapeutic device.
No
The ReForm Pedicle Screw System is a posterior spinal fixation system designed to provide immobilization and stabilization, acting as an adjunct to fusion for various spinal conditions. Its function is to mechanically support the spine, not to diagnose medical conditions or analyze data to provide diagnostic information.
No
The device description clearly states it is a "multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws," indicating it is a hardware-based implant system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The ReForm Pedicle Screw System is a physical implantable device consisting of screws, rods, and other components used to stabilize the spine. It is surgically implanted into the patient's body.
- Intended Use: The intended use describes the device's purpose as providing "immobilization and stabilization of spinal levels... as an adjunct to fusion." This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The information provided clearly indicates this is a surgical implant for spinal fixation, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ReForm Pedicle Screw System is intended to provide immobilization 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, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeietally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis) spinal tumor; pseudoarthrosis; and failed previous fusion.
Product codes
MNI, MNH
Device Description
The ReForm Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature 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
The following tests were conducted:
- Static and dynamic compression per ASTM F1717 .
- Static torsion per ASTM F1717 .
The results of this testing indicate that the ReForm Pedicle Screw System is equivalent to predicate device(s).
No clinical studies were performed
Key Metrics
Not Found
Predicate Device(s)
S-LOK (K092128)
Reference Device(s)
K071438, K073240, K090033, K092128, K061520, K111571
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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AUG 8 2012
510(k) Summary for the ReForm Pedicle Screw System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the ReForm Pedicle Screw System
GENERAL INFORMATION 1.
| Date Prepared: | April 3, 2012 |
|---|---|
| Trade Name: | ReForm Pedicle Screw System |
| Common Name: | pedicle screw system |
| Classification Name: | orthosis, spinal pedicle fixation |
| orthosis, spondylolisthesis spinal fixation | |
| Class: | II |
| Product Code: | MNI |
| MNH | |
| CFR section: | 21 CFR section 888.3070 |
| Device panel: | Orthopedic |
| Legally Marketed | PSS System (K071438 / K073240 / K090033/K092128) |
| Viper Spine System (K061520 / K111571) | |
| Predicate Device: | S-LOK (K092128) |
| Submitter: | Spinal USA |
| 2050 Executive Drive | |
| Pearl, MS 39208 | |
| 601-420-424 | |
| Contact: | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| 512-692-3699 Fax | |
| e-mail: idwebb@orthomedix.net |
2. DEVICE DESCRIPTION
The ReForm Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Change from Predicate:
The purpose of this submission is to make modifications/additions to the components of the PSS System cleared in K071438/ K073240/ K090033/ K092128. The standard construct is modified by a variety of additional/modified screws and rods.
Materials:
Ti-6AI-4V ELI per ASTM F136 CoCr per ASTM F1537
Pj lod 2
1
3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES
The ReForm Pedicle Screw System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.
4. INTENDED USE
The ReForm Pedicle Screw System is intended to provide immobilization 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, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeietally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis) spinal tumor; pseudoarthrosis; and failed previous fusion.
NON-CLINICAL TEST SUMMARY 5.
The following tests were conducted:
- Static and dynamic compression per ASTM F1717 .
- Static torsion per ASTM F1717 .
The results of this testing indicate that the ReForm Pedicle Screw System is equivalent to predicate device(s).
6. CLINICAL TEST SUMMARY
No clinical studies were performed
7. CONCLUSIONS NONCLINICAL AND CLINICAL
This summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the ReForm Pedicle Screw System is as safe, as effective, and performs as well as or better than the predicate device(s).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 8 2012
Spinal USA % Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K121172
Trade/Device Name: ReForm Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: July 05, 2012 Received: July 11, 2012
Dear Mr. Webb:
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 for associated in the 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 (1111). Tournal controls provisions of the Act include requirements for annual registration, Intel. The gollera, good manufacturing practice, labeling, and prohibitions against misbranding nsting of doviets, good manarational group 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 If your device is elaborited (books). 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 I lease be devised alla I Dr i batian that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I outlar states and a mot and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
3
Page 2 - Mr. J.D. Webb
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de vice-related udverse ovents) (2) 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 11 you desire specific advice to: your conters Offices/CDRH/CDRHOffices/ucm115809.htm for go to intp://www.laa.gov.il. Radiological Health's (CDRH's) Office of Compliance. Also, please the Comer for Do reces than by by reference to premarket notification" (21CFR Part now the regulation online 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 Tou may ookun one. generar morniemational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (000) 050 2014 11 2014 MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ReForm Pedicle Screw System
Indications for Use:
The ReForm Pedicle Screw System is intended to provide immobilization and stabilization of spinal r relevels in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and obginonic in sittlies or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spiral tumor, and failed previous fusion (pseudarthrosis).
The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patiently includion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended opine (Le to Gaeran) man reveal (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis) spinal tumor; pseudoarthrosis; and failed previous fusion.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and/Restorative Devices
KI21172 510(k) Number.