(113 days)
The ReForm Pedicle Screw System is intended to provide immobilization and stabilization of spinal re 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.
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.
The ReForm Pedicle Screw System is a medical device, and the provided text is a 510(k) summary for its clearance. Medical devices, especially implants like pedicle screw systems, typically demonstrate performance through mechanical testing rather than clinical studies or AI algorithm evaluations. Therefore, many of the requested categories related to AI performance, expert consensus, and human reader studies are not applicable to this device submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Type) | Reported Device Performance (Results) |
|---|---|
| Static compression per ASTM F1717 | Equivalent to predicate device(s) |
| Dynamic compression per ASTM F1717 | Equivalent to predicate device(s) |
| Static torsion per ASTM F1717 | Equivalent to predicate device(s) |
Note: The specific quantitative acceptance limits (e.g., minimum load, cycles to failure) are not provided in this 510(k) summary, but the general outcome is stated as "equivalent to predicate device(s)". Equivalence implies that the ReForm Pedicle Screw System achieved performance comparable to, or better than, the predicate devices in these mechanical tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. For mechanical tests, the "sample size" refers to the number of test specimens (e.g., screw constructs, rod-screw assemblies) subjected to testing. This information is typically found in the full test report, not usually in the 510(k) summary.
- Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective clinical data, as this concerns mechanical testing of manufactured components. The data originates from non-clinical laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This device is evaluated using objective mechanical engineering tests (ASTM F1717). There is no "ground truth" in the sense of expert medical diagnosis or interpretation required for these performance assessments. The performance is determined by physical measurements and engineering standards.
4. Adjudication Method for the Test Set
- Not applicable. As the performance is determined by objective mechanical testing against engineering standards, there is no need for an adjudication method by medical experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.
- Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as this is a mechanical spinal fixation system, not an AI-driven diagnostic or assistive device for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This is a hardware medical device, not a software algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance. The "ground truth" for this device's performance is established by its ability to meet standardized mechanical test requirements (ASTM F1717) and demonstrate equivalence to the performance of previously cleared predicate devices.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. Its design and materials undergo engineering validation.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this device does not utilize a "training set" in the context of AI/ML. The "ground truth" for its design and materials is established through engineering principles, material science, and compliance with relevant ASTM standards.
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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 fixationorthosis, spondylolisthesis spinal fixation |
| Class: | II |
| Product Code: | MNIMNH |
| 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 USA2050 Executive DrivePearl, MS 39208601-420-424 |
| Contact: | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Tele512-692-3699 Faxe-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
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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).
P, 2 of 2
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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
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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
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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.
§ 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.