K Number
K212937
Device Name
Dakota ALIF Plate System
Date Cleared
2021-11-04

(50 days)

Product Code
Regulation Number
888.3060
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dakota ALIF Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Dakota ALIF Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Device Description
The Dakota ALIF Plate System consists of a series of plates and screw sizes, along with the necessary surgical instrumentation. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) to provide stabilization and permit spinal fusion to occur. All components are made from Ti-6Al-4V per ASTM F136 or ISO and 5832-3. The products are supplied clean and non-sterile.
More Information

Not Found

No
The summary describes a mechanical implant (plate and screws) for spinal fixation and does not mention any software, algorithms, or AI/ML capabilities.

Yes
The device is described as a "supplemental fixation device" intended to provide "temporary fixation" and "stabilization" to permit spinal fusion. These functions are directly involved in treating or alleviating a medical condition (degenerative disc disease, spondylolisthesis, trauma, etc.) by promoting healing and stabilizing the spine, which aligns with the definition of a therapeutic device.

No
The device is described as a "supplemental fixation device" and a "temporary fixation device" used for spinal fusion, which is a treatment, not a diagnostic procedure.

No

The device description explicitly states it consists of "a series of plates and screw sizes, along with the necessary surgical instrumentation," which are physical hardware components.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body.
  • Dakota ALIF Plate System Function: The description clearly states that the Dakota ALIF Plate System is a surgical implant used for spinal fixation. It is a physical device implanted inside the body to provide structural support and stabilization.

The information provided about the device's intended use, description, materials, and performance testing all point to it being a surgical implant, not an IVD.

N/A

Intended Use / Indications for Use

The Dakota ALIF Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Dakota ALIF Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Product codes (comma separated list FDA assigned to the subject device)

KWQ

Device Description

The Dakota ALIF Plate System consists of a series of plates and screw sizes, along with the necessary surgical instrumentation. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) to provide stabilization and permit spinal fusion to occur. All components are made from Ti-6Al-4V per ASTM F136 or ISO and 5832-3. The products are supplied clean and non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior lumbar (L1-S1)

Indicated Patient Age Range

Not Found

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 Dakota ALIF Plate System has been tested in the following test modes:

  • Static Compression Bending per ASTM F1717
  • Static Torsion per ASTM F1717
  • Dynamic Compression Bending per ASTM F1717
    The results of this non-clinical testing show that the strength of the Dakota ALIF Plate 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.

K091044, K080429

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

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.

0

November 4, 2021

Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Precision Spine, Inc. % Nathan Wright Engineer and Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K212937

Trade/Device Name: Dakota ALIF Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ, Dated: September 14, 2021 Received: September 15, 2021

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 (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 located 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.

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

1

801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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).

Sincerely,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known)

K212937

Device Name

Dakota ALIF Plate System

Indications for Use (Describe)

The Dakota ALIF Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Dakota ALIF Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

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) CONTINUE ON A SEPARATE PAGE IF NEEDED. 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. "

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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510(K) SUMMARY

Submitter's Name:Precision Spine, Inc.
Submitter's Address:2050 Executive Dr.
Pearl, Mississippi 39208
Submitter's Telephone:601-420-4244
Contact Person:Nathan Wright MS
Empirical Testing Corp.
1-719-351-0248
nwright@empiricaltech.com
Image: Empirical Testing Corp. Logo
Date Summary was Prepared:September 14, 2021
Trade or Proprietary Name:Dakota ALIF Plate System
Common or Usual Name:Appliance, Fixation, Spinal Intervertebral Body
Classification:Class II per 21 CFR §888.3060
Product Code:KWQ
Classification Panel:Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Dakota ALIF Plate System consists of a series of plates and screw sizes, along with the necessary surgical instrumentation. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) to provide stabilization and permit spinal fusion to occur. All components are made from Ti-6Al-4V per ASTM F136 or ISO and 5832-3. The products are supplied clean and non-sterile.

INDICATIONS FOR USE

The Dakota ALIF Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The Dakota ALIF Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), 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), deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences in geometry do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

  • Indications for Use

4

  • Materials of manufacture .
  • Structural support mechanism ●

| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Product
Code | Predicate
Type |
|-------------------------------|---------------------------------------------|-------------------------------------|-----------------|-------------------|
| K091044 (Primary),
K070922 | Spinal USA Anterior
Lumbar Plate System | Spinal USA
(Precision Spine) | KWQ | Primary |
| K080429 | PYRAMID® +4 Anterior
Lumbar Plate System | Medtronic
Sofamor Danek,
Inc. | KWQ | Additional |

Performance Data

The Dakota ALIF Plate System has been tested in the following test modes:

  • Static Compression Bending per ASTM F1717 ●
  • Static Torsion per ASTM F1717
  • Dynamic Compression Bending per ASTM F1717 ●

The results of this non-clinical testing show that the strength of the Dakota ALIF Plate 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 conclusion that the Dakota ALIF Plate System is substantially equivalent to the predicate device.