(206 days)
The LAGUNA™ Monoaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: 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 Laguna™ Monoaxial Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space.
The Laguna Spinal System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The additional monoaxial screws are supplied in winged and non-winged configurations from 30 to 80 mm length and in 5mm, 6mm, 7mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only.
The Laguna Spinal System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.
The provided text focuses on the 510(k) summary for the Allez Spine Laguna Monoaxial Pedicle Screw System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain details about acceptance criteria, a specific study proving those criteria, or information on AI/standalone algorithm performance, ground truth establishment, or multi-reader multi-case studies.
The document primarily states that:
- Performance Data: "Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading."
This single statement is the extent of the performance data provided in this specific 510(k) summary. It does not elaborate on specific acceptance criteria, study methodologies, sample sizes, expert involvement, or AI aspects.
Therefore, I cannot fulfill the request for information on acceptance criteria and study details as they are not present in the provided text.
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510(k) Summary of Safety and Effectiveness
[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
| Contact: | Mr. Hartmut LochRegulatory ConsultantOfficial FDA CorrespondentTel: 619-885-7733 - Fax: 760-632-9133c/o Allez Spine, LLC.19772 Mac Arthur Blvd., Suite 150Irvine, CA 92612 |
|---|---|
| Trade name: | Allez Spine Laguna™ Monoaxial Pedicle Screw System |
| Common name: | Spinal Fixation System |
| Classificationname: | Appliance, Fixation, Spinal Interlaminal - § 888.3050 (KWP) - class IIOrthosis, Spinal Pedicle Fixation - § 888.3070 (MNI) - class IIOrthosis, Spondylolisthesis Spinal Fixation - § 888.3070 (MNH) - class IIOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease- § 888.3070 (NKB) - class IIIAll Orthopedic Device Panel 87 |
| Product Code: | KWP, KWQ, MNI, MNH & NKB |
| Device Descriptionand Characteristics: | The Laguna™ Monoaxial Pedicle Screw System is intended to helpprovide correction, immobilization and stabilization of spinal segments asan adjunct to fusion of the thoracic, lumbar and/or sacral space.The Laguna Spinal System consists of a variety of rods and screws, whichcan be rigidly locked into a variety of configurations, with each constructbeing tailor made for the individual case. The additional monoaxialscrews are supplied in winged and non-winged configurations from 30 to80 mm length and in 5mm, 6mm, 7mm and 8mm diameter sizes. All sizesare able to receive 5.5mm connecting rods only.The Laguna Spinal System implant components are fabricated frommedical grade titanium alloy described by such standards as ASTM F136or ISO 5832-3 or 5832-2. |
| Equivalence: | The Laguna™ Monoaxial Pedicle Screw System is substantiallyequivalent to the Laguna™ (polyaxial) Pedicle Screw System, which ismanufactured and marketed by Allez Spine, LLC - K050060 S/E May 4,2005 |
| Indications: | The Laguna Spinal System is intended for posterior, non-cervical fixationfor the following conditions: degenerative disc disease (defined as backpain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies); spondylolisthesis; trauma (i.e. fractureor dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/orlordosis); tumor pseudarthrosis; and/or failed previous fusion. |
| Performance data: | Biomechanical tests have been performed. The test results wereequivalent to other similar implants and are sufficient for in vivo loading. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a symbol that resembles a stylized caduceus, featuring a staff with three intertwined snakes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 9 2005
2005
Allez Spine, LLC c/o Mr. Hartmut Loch HHL Consulting 2009 Freda Lane Cardiff, California 92007
Re: K051275
Trade Name: Laguna Pedicle Screw System – Addition of Monoaxial Screws Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, MNH, MNI, KWP Dated: December 2, 2005 Received: December 2, 2005
Dear Mr. Loch:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(ty prematics is substantially equivalent (for the indications
referenced above and have determined the device is substantials in interstate for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regally manketed producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prof to May 20, 1970, the charger and state show is the Federal Food. Drug, devices that have been recilassified in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosment Act (Act) that do not require to the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general registration, lis You may, therefore, market the device, seeject to the most general controls provisions of the Fiel merator requirement misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) nito effective major regulations affecting your device can
may be subject to such additional controls. Title may be subject to such additional controlis. Existing major be found in the Code of I edetal regarations, our device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice or a stablics with other requirements of the Act
that FDA has made a determination that your device coloral econoies. You must that FDA has made a decernmanon that your be room as receral agencies. You must a or any Federal statutes and regulations daministered of not limited to: registration and listing (21 little comply with an the Act s requirements, mercessed manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Fart 801), good manata 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000) 11 CFR 1000 1050 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
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Page 2 – Mr. Hartmut Loch
This letter will allow you to begin marketing your device as described in your Section 510(k) Premarket notification. The FDA finding of substantial equivalence of your device to a legally premaince hotification. The a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire specific acripUiance at (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Connerset notification" (21CFR Part 807.97). You may obtain Missianding of Yeference to premail.orginism.com ine Act from the Division of Small other general mionmation on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
2
Sy Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name(s): LAGUNA™ Monoaxial Pedicle Screw System
Indications for Use:
The LAGUNA™ Monoaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: 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.
Prescription Use x x x Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
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510(k) Number K051275
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