(62 days)
Not Found
No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a system that promotes fusion of the cervical and upper thoracic spine for various conditions like DDD, spondylolisthesis, and spinal stenosis, indicating it is used to treat or manage a disease or condition.
No
The device is described as a "Posterior Cervical/Upper Thoracic System" consisting of screws, rods, and hooks intended to "promote fusion" and provide "stabilization." These are all components used in surgical procedures for treatment, not diagnosis. The "Indications for Use" list conditions like DDD, Spondylolisthesis, and Spinal Stenosis, which are conditions the device treats, not diagnoses.
No
The device description explicitly states it consists of physical components (polyaxial screws, rods, and hooks) made from titanium alloy, indicating it is a hardware-based medical device.
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 provided text describes a system of implants (screws, rods, and hooks) made of titanium alloy that are surgically implanted into the cervical and upper thoracic spine.
- Intended Use: The intended use is to promote fusion and provide stabilization in the spine for various conditions. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The device described is a surgical implant used for spinal fusion and stabilization.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine (CI-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:
-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies)
-Spondylolisthesis
-Spinal Stenosis
-Fracture/dislocation
-Revision of previous cervical spine surgery
-Tumors
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The Sure Lok Mini Posterior Cervical/Upper Thoracic System consists of polyaxial screws, rods and hooks. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium alloy. The components will be provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (CI-C7), upper thoracic spine (T1-T3)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following mechanical testing was performed on the Sure Lok Mini Posterior Cervical/Upper Thoracic System. Testing was performed according to ASTM F1717: Static Axial Compression Bending test, Static Torsion test, Dynamic Axial Compression Bending test, and Dynamic Torsion test.
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.
Synthes - Cervifix System (K991089), Alphatec - Solanas System (K052201), Seaspine - Sierra System (K072729)
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
K112025 page 1/2
SEP 1 5 2011
Image /page/0/Picture/2 description: The image shows the logo for Spinal USA. The words "Spinal USA" are written in white letters on a black rectangle. A drawing of a spine is between the words "Spinal" and "USA".
2050 Executive Drive Pearl, MS 39208
Ph: 601-420-4244 Fax: 601-420-5501
510(k) Summary
| Date Summary Prepared: | July 11, 2011 |
|---|---|
| Submitter Information: | Spinal USA |
| 2050 Executive Drive | |
| Pearl, MS 39208 | |
| Contact Name: | |
| Phone: | |
| Fax: | |
| E-mail: | Frankie Cummins |
| 601-420-4244 | |
| 601-420-5501 | |
| fc@spinalusa.com | |
| Device Trade Name: | Sure Lok Mini Posterior Cervical/Upper Thoracic System |
| Common Name: | Spinal Interlaminal Fixation Orthosis |
| Regulatory Number: | 888.3050 |
| Classification: | Class II |
| Product Code: | K WP |
| Predicate Device: | Synthes - Cervifix System (K991089) |
| Alphatec - Solanas System (K052201) | |
| Seaspine - Sierra System (K072729) |
INTENDED USE:
When intended to promote fusion of the cervical spine (CI-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:
-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies) -Spondylolisthesis
1
K112025 page 2/2
-Spinal Stenosis -Fracture/dislocation
- -Revision of previous cervical spine surgery
- -Tumors
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.
DEVICE DESCRIPTION:
The Sure Lok Mini Posterior Cervical/Upper Thoracic System consists of polyaxial screws, rods and hooks. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from titanium alloy. The components will be provided non-sterile.
EQUIVALENT DEVICE:
Documentation was provided which demonstrated the Sure Lok Mini Posterior Cervical/Upper Thoracic System is substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture.
Components of the Sure Lok Mini Posterior Cervical/Upper Thoracic System are similar to the predicate systems. The design concept of the polyaxial pedicle screw of the Solanas and Sierra systems are similar to the Sure Lok Mini Posterior Cervical/Upper Thoracic system. The screw thread type, size and length are similar as is the polyaxial ball joint locking mechanism and rod clamping cap screw. The same applies to the rescue screw design. The cap screw torque applied to seat the cap screw is similar to the predicates. Screw angulation is also similar. Rod design is similar to the predicate systems. Rod diameter is either the same or larger. Rod lengths are similar to the predicates. Hook type, shape, size are similar to the predicates. Cross links, domino, and offsets are similar to the predicates. Material is the same as the predicates. Sterilization is the same as the predicates.
The following mechanical testing was performed on the Sure Lok Mini Posterior Cervical/Upper Thoracic System. Testing was performed according to ASTM F1717: Static Axial Compression Bending test, Static Torsion test, Dynamic Axial Compression Bending test, and Dynamic Torsion test.
2
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 stylized graphic of an eagle or bird-like figure with three wing-like shapes. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 1 (090)3 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spinal USA % Mr. Frankie Cummins 2050 Executive Drive Pearl, Mississippi 39208
SEP 15 2001
Re: K112025
Trade/Device Name: Sure Lok Mini Posterior Cervical/ Upper Thoracic System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class H Product Code: KWP Dated: July 13, 2011 Received: July 15, 2011
Dear Mr. Cummins:
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
3
Page 2 - Mr. Frankie Cummins
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours,
Sincerely yours,
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
Device Name: Sure Lok Mini Posterior Cervical/Upper Thoracic System
Indications for Use:
When intended to promote fusion of the cervical spine (CI-C7) in skeletally mature patients, the Sure Lok Mini Posterior Cervical/Upper Thoracic System is indicated for the following:
-DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiologic studies) -Spondylolisthesis -Spinal Stenosis -Fracture/dislocation -Revision of previous cervical spine surgery -Tumors
The use of polyaxial screws is limited to placement in the upper.thoracic spine (T1-T3) for the purposes of anchoring the construct. Polyaxial screws are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical (C1-C7) spine.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________