(57 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities. The performance studies are based on mechanical testing standards.
Yes
The device is intended to provide immobilization and stabilization of spinal segments as an "adjunct to fusion" for various spinal conditions, indicating a therapeutic role in treating medical conditions.
No
Explanation: The LOCK-IN Spinal Fixation System is a surgical implant designed to provide immobilization and stabilization of spinal segments. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists physical components made of Ti-6Al-4V ELI titanium alloy, such as screws, rods, rod lockers, and crosslinks, and describes mechanical testing performed on these components. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The LOCK-IN Spinal Fixation System is a physical implantable device consisting of screws, rods, and other components made of titanium alloy. It is surgically implanted into the spine.
- Intended Use: The intended use is for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for various spinal conditions. This involves providing structural support and stabilization within the body.
The device is a surgical implant used in vivo (within the living body) for mechanical support and stabilization, not for testing samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The LOCK-IN Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
The LOCK-IN Spinal Fixation System is intended to be used with autograft and/or allograft.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The LOCK-IN Spinal Fixation System is a spinal pedicle fixation system consisting of polyaxial pedicle screws (expandable and non-expandable; cannulated and non-cannulated), rods (straight and curved), rod lockers, and crosslinks. All components are manufactured from Ti-6Al-4V ELI titanium alloy. All screws are available with either standard or spondylolisthesis head configurations. Fixation is provided via a posterior approach.
The LOCK-IN Spinal Fixation System expandable pedicle screws increase screw pullout strength when compared to similarly sized conventional screws. These screws are recommended for cases when increased fixation strength is desired.
The LOCK-IN Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion in the non-cervical spine, including the thoracic, lumbar and/or sacral spine (T1-S5). The LOCK-IN Spinal Fixation System consists of a variety of shapes and sizes of rods, screws, cross connectors that provide internal fixation and stabilization during bone graft healing and /or fusion mass development.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical fixation in skeletally mature patients, non-cervical spine, including the thoracic, lumbar and/or sacral spine (T1-S5)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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 LOCK-IN Spinal Fixation System is substantially equivalent to the listed predicate devices in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", issued May 3, 2004.
The following tests were performed to show equivalency:
ASTM F543 Pedicle Screw Pull-Out, Driving Torque, and Torsional Testing ASTM F1717 Static / Compressive Bending and Torsional Testing ASTM F2193 Static and Dynamic Cantilever Bending Testing ASTM F1798 Tulip Disassociation Testing Expandable Screw Reversibility Characterization Testing Expandable Screw Cadaver Pullout Comparative Performance Study
The results of these studies show the subject LOCK-IN Spinal Fixation System is substantially equivalent to the predicate device.
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.
K992333, K102331, K124058, K151704, K201457, K203507
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.
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December 13, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
LOCK-IN USA CORP
% Justin Gracyalny Regulatory Affairs Program Manager Secure BioMed Evaluations 7828 Hickory Flat Hwv Suite 120 Woodstock, Georgia 30188
Re: K243281
Trade/Device Name: LOCK-IN Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: October 17, 2024 Received: October 17, 2024
Dear Justin Gracyalny:
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).
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Sincerely,
Colin Colin - Colin
O'neill -SFD
D'neill -SFFD
Clineill -SFFD
Chief -SFFD
Chief - Street - Street - Street - Street - Street - Street - Street - Street - Street - Street - Str
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
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Indications for Use
510(k) Number (if known) K243281
Device Name LOCK-IN Spinal Fixation System
Indications for Use (Describe)
The LOCK-IN Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
The LOCK-IN Spinal Fixation System is intended to be used with autograft and/or allograft.
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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510(k) Summary
| Date | December 3, 2024 |
|---|---|
| Sponsor | LOCK-IN USA CORP |
| 3411 Silverside Road, Tatnall Building #104 | |
| Wilmington, DE 19810 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Justin Gracyalny, MSE | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| Regulatory@SecureBME.com | |
| Trade Name | LOCK-IN Spinal Fixation System |
| Common Name | Thoracolumbosacral Pedicle Screw System |
| Code- | |
| Classification | NKB - Thoracolumbosacral Pedicle Screw System (21 CFR §888.3070) |
| Primary | |
| Predicate | K992333 Electro-Biology, Inc. EBI Omega 21™ System |
| Additional | |
| Predicates | K102331 LDR Spine USA SpineTune™ TL Spinal System |
| K124058 Globus Medical Inc. CREO™ Stabilization System | |
| K151704 SIGNUS Medizintechnik GmbH DIPLOMAT® Spinal System | |
| K201457 Auxein Medical Private Limited Vertaux 5.5 mm Pedicle Screw | |
| System | |
| K203507 Zimmer Biomet Spine, Inc. Vitality® Spinal Fixation System | |
| Device | |
| Description | The LOCK-IN Spinal Fixation System is a spinal pedicle fixation system |
| consisting of polyaxial pedicle screws (expandable and non-expandable; | |
| cannulated and non-cannulated), rods (straight and curved), rod lockers, and | |
| crosslinks. All components are manufactured from Ti-6Al-4V ELI titanium | |
| alloy. All screws are available with either standard or spondylolisthesis | |
| head configurations. Fixation is provided via a posterior approach. |
The LOCK-IN Spinal Fixation System expandable pedicle screws increase
screw pullout strength when compared to similarly sized conventional screws.
These screws are recommended for cases when increased fixation strength is
desired.
The LOCK-IN Spinal Fixation System is intended to help provide
immobilization and stabilization of spinal segments as an adjunct to fusion in
the non-cervical spine, including the thoracic, lumbar and/or sacral spine (T1-
S5). The LOCK-IN Spinal Fixation System consists of a variety of shapes and
sizes of rods, screws, cross connectors that provide internal fixation and
stabilization during bone graft healing and /or fusion mass development. |
| Indications for
Use | The LOCK-IN Spinal Fixation System is intended for posterior, non-
cervical fixation in skeletally mature patients as an adjunct to fusion for the
following indications: degenerative disc disease (defined as back pain of
discogenic origin with degeneration of the disc confirmed by history and
radiographic studies); spondylolisthesis; trauma (i.e., fracture or
dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or
lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
The LOCK-IN Spinal Fixation System is intended to be used with autograft
and/or allograft. |
| Technological
Characteristics | There are no significant technological differences between the subject and
predicate device. Minor differences in component geometry and size offerings
are addressed via performance testing and via comparison to the
cleared technological additional predicates. The technological design
features of the subject implants were compared to the predicate in
intended use, indications for use, design, function and technology and it
was demonstrated that they are substantially equivalent. |
| Performance
Testing | Non-clinical testing was performed to demonstrate the LOCK-IN Spinal
Fixation System is substantially equivalent to the listed predicate devices
in accordance with "Guidance for Industry and FDA Staff, Guidance for
Spinal System 510(k)s", issued May 3, 2004.
The following tests were performed to show equivalency:
ASTM F543 Pedicle Screw Pull-Out, Driving Torque, and
Torsional Testing ASTM F1717 Static / Compressive Bending and Torsional Testing ASTM F2193 Static and Dynamic Cantilever Bending Testing ASTM F1798 Tulip Disassociation Testing Expandable Screw Reversibility Characterization Testing Expandable Screw Cadaver Pullout Comparative Performance
Study The results of these studies show the subject LOCK-IN Spinal Fixation
System is substantially equivalent to the predicate device. |
| Conclusions | Based on the indications for use, technological characteristics, performance
testing, and comparison to the predicate device, the subject LOCK-
IN Spinal Fixation System is substantially equivalent to the legally
marketed predicate. |
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