(65 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is described as promoting fusion and providing stabilization, which are therapeutic actions aimed at treating conditions like DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, revision of previous cervical spine surgery, and tumors.
No
This device is a surgical system (implants like screws, rods, and hooks) intended to promote fusion and provide stabilization in the spine, not to diagnose medical conditions.
No
The device description explicitly states that the Sure Lok Mini Posterior Cervical/Upper Thoracic System consists of physical components (polyaxial screws, rods, and hooks) fabricated from titanium alloy. This indicates a hardware-based medical device, not a software-only one.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text describes a surgical implant system (screws, rods, and hooks) used to stabilize the spine and promote fusion. It is implanted directly into the patient's body during surgery.
- Lack of IVD Characteristics: There is no mention of testing biological samples, analyzing bodily fluids, or providing diagnostic information based on laboratory analysis.
This device is a surgical implant used for structural support and stabilization within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine (Cl-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
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 (Cl-C7), upper thoracic spine (T1-T3)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Risk analysis was conducted and led to the determination that additional mechanical testing is not required in order to establish the substantial equivalency of the subject devices to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/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 a stylized image of three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 4, 2015
Precision Spine, Incorporated % Meredith May, MS, RAC Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K150851
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 II Product Code: KWP Dated: May 6, 2015 Received: May 7, 2015
Dear Ms. May:
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 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 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known)
Device Name
Sure Lok Mini Posterior Cervical/Upper Thoracic System
Indications for Use (Describe)
When intended to promote fusion of the cervical spine (Cl-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.
Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D) [ ] Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services
Food and Drug Administration Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff(@fda.hhs.gov
" An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| Submitter's Name: | Precision Spine |
|---|---|
| Submitter's Address: | 2050 Executive Drive |
| Pearl, MS 39208 | |
| Submitter's Telephone: | 973-455-7150 |
| Contact Person: | Meredith May, MS, RAC |
| Empirical Consulting, LLC | |
| 719.337.7579 | |
| Date Summary was Prepared: | 27 March 2015 |
| Trade or Proprietary Name: | Sure Lok Mini Posterior Cervical/Upper Thoracic System |
| Common or Usual Name: | Spinal interlaminal fixation orthosis |
| Classification: | Class II per 21 CFR §888.3050 |
| Product Code: | KWP |
| Classification Panel: | Orthopedic Devices |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
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 allov. The components will be provided non-sterile.
INDICATIONS FOR USE
When intended to promote fusion of the cervical spine (C1-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.
5
TECHNICAL CHARACTERISTICS
The Sure Lok Mini Posterior Cervical/Upper Thoracic System is made from titanium alloy material that conforms to ASTM F136. The modification to the subject system, the addition of smooth shank screws, 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 identical between the subject and predicates:
- . Indications for Use
- Materials of manufacture
- . Structural support mechanism
Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K112025 | Sure Lok Mini Posterior | ||
| Cervical/Upper Thoracic System | Precision Spine | Primary | |
| K142741 | OASYS® | Stryker Spine | Additional |
PERFORMANCE DATA
Risk analysis was conducted and led to the determination that additional mechanical testing is not required in order to establish the substantial equivalency of the subject devices to the predicate devices.
CONCLUSION
The overall technology characteristics and mechanical engineering analysis lead to the conclusion that the Sure Lok Mini Posterior Cervical/Upper Thoracic System is substantially equivalent to the predicate devices.