(137 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as "intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of instabilities or deformities of the thoracic, lumbar, and sacral spine," which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device is a pedicle screw system intended for immobilization and stabilization of spinal segments as an adjunct to fusion. This is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines a system composed of physical components like screws, rods, and connectors made from various metal alloys, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for the mechanical stabilization and fusion of the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, and connectors, which are typical of surgical implants. It also mentions the use of bone cement for augmentation, further indicating a therapeutic application.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
Therefore, the Reform Pedicle Screw System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal seqments 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; degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the G21 and Precision Spine Cement Cannula for mixing and injection of bone cements, the fenestrated Reform pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The fenestrated Reform pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Product codes (comma separated list FDA assigned to the subject device)
NKB, PML
Device Description
The Reform Pedicle Screw System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, dominoes, and lateral offsets. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium alloy described by such standards as ASTM F158, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The products are supplied clean and "non-sterile". The Fenestrated Screws allow the augmentation of PMMA bone cement to the insertion site. These modular Fenestrated Screws are assembled during surgery with the Reform Standard Modular Tulips or the Reform Reduction Modular Tulips which were cleared under K150856 and their compatible rods and set screws. The Fenestrated Screws are to be used with the G21 V-Fast Bone Cement or V-Steady Bone Cement cleared under K150408. Bone Cement is delivered into the pedicle screw and bone through the delivery instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine; non-cervical pedicle
Indicated Patient Age Range
skeletally mature patients; pediatric patients; adolescent
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)
The Reform Pedicle Screw System has been tested in the following test modes:
- Dynamic Compression Bending per ASTM F1717
- Bone Cement Injection Testing
The results of this non-clinical testing show that the performance of the Reform Pedicle Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
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
December 17, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Precision Spine, Inc. % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K242297
Trade/Device Name: Reform Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB. PML Dated: November 26, 2024 Received: November 26, 2024
Dear Nathan Wright:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Colin . O'neill -S
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K242297
Device Name
Reform Pedicle Screw System
Indications for Use (Describe)
The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal seqments 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; degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the G21 and Precision Spine Cement Cannula for mixing and injection of bone cements, the fenestrated Reform pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The fenestrated Reform pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K242297 - 510(K) SUMMARY
| Submitter's Name: | Precision Spine, Inc. |
|---|---|
| Submitter's Address: | 2050 Executive Drive |
| Pearl, Mississippi 39208 | |
| Submitter's Telephone: | 201-953-0500 |
| Contact Person: | Nathan Wright, MS, RAC |
| Empirical Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: [Empirical Technologies logo] | |
| Date Summary was Prepared: | August 1, 2024 |
| Trade or Proprietary Name: | Reform Pedicle Screw System |
| Device Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Classification & Regulation #: | Class II per 21 CFR §888.3070, §888.3027 |
| Product Code: | NKB, PML |
| Classification Panel: | Orthopedic - Spinal (DHT6B) |
PURPOSE OF SUBMISSION:
The purpose of this submission to offer fenestrated screws in the previously cleared Reform Pedicle Screw System for bone cement injection.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Reform Pedicle Screw System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, dominoes, and lateral offsets. All of the components are available in a variety of sizes to match more closely the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium alloy described by such standards as ASTM F158, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The products are supplied clean and "non-sterile". The Fenestrated Screws allow the augmentation of PMMA bone cement to the insertion site. These modular Fenestrated Screws are assembled during surgery with the Reform Standard Modular Tulips or the Reform Reduction Modular Tulips which were cleared under K150856 and their compatible rods and set screws. The Fenestrated Screws are to be used with the G21 V-Fast Bone Cement or V-Steady Bone Cement cleared under K150408. Bone Cement is delivered into the pedicle screw and bone through the delivery instrumentation.
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 the thoracic. lumbar, and sacral spine: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the G21 and Precision Spine Cement Cannula for mixing and injection of bone cements, the fenestrated Reform pedicle
5
screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The fenestrated Reform pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
TECHNOLOGICAL CHARACTERISTICS
Predicate Devices
| 510k # | Trade or Proprietary Name | Manufacturer | Product Code | Type |
|---|---|---|---|---|
| K200596 | G21 Cement, Vader® Pedicle System | Icotec AG | PML, NKB | Primary |
| K193011 | CD Horizon Fenestrated Screw Set | Medtronic Sofamor Danek USA, Inc. | NKB | Additional |
| K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | NKB, KWP, MNH, MNI, OSH | Additional |
The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are same between the subject and predicates:
- Indications for Use ●
- Structural Support Mechanism and Function
- Materials of manufacture ●
- Sterility ●
- Sizes
- . Manufacturing and Biocompatibility
Difference is fenestration diameters and differences in quantity of fenestrations at the screw tip do not raise questions for safety and efficacy since bone cement injection testing was performed with the subject fenestrated screws which demonstrated successful injection of bone cement through the fenestrations.
Performance Data
The Reform Pedicle Screw System has been tested in the following test modes:
- Dynamic Compression Bending per ASTM F1717 ●
- Bone Cement Injection Testing
The results of this non-clinical testing show that the performance of the Reform Pedicle Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the Reform Pedicle Screw System is substantially equivalent to the predicate device.