(206 days)
Not Found
No
The 510(k) summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an implantable pedicle screw system intended for providing correction, immobilization, and stabilization of spinal segments as an adjunct to fusion, which acts as a structural support rather than directly providing therapy.
No
This device is a surgical implant designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It is a treatment device, not a diagnostic one.
No
The device description clearly states it consists of physical components like rods and screws made of titanium alloy, which are hardware.
Based on the provided information, 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 LAGUNA™ Monoaxial Pedicle Screw System is a surgical implant intended for posterior spinal fixation. It is used in the body to provide structural support and stabilization.
- Lack of Diagnostic Testing: The description does not mention any testing of samples or diagnostic procedures. Its purpose is purely mechanical and structural support within the body.
Therefore, the LAGUNA™ Monoaxial Pedicle Screw System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Laguna Spinal 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.
Product codes (comma separated list FDA assigned to the subject device)
KWP, KWQ, MNI, MNH & NKB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical
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)
Biomechanical tests have been performed. The test results were equivalent to other similar implants and are sufficient for in vivo loading.
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.
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.
0
510(k) Summary of Safety and Effectiveness
[in accordance with SMDA of 1990, 21 CFR 807.92(c)]
| Contact: | Mr. Hartmut Loch
Regulatory Consultant
Official FDA Correspondent
Tel: 619-885-7733 - Fax: 760-632-9133
c/o Allez Spine, LLC.
19772 Mac Arthur Blvd., Suite 150
Irvine, CA 92612 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name: | Allez Spine Laguna™ Monoaxial Pedicle Screw System |
| Common name: | Spinal Fixation System |
| Classification
name: | Appliance, Fixation, Spinal Interlaminal - § 888.3050 (KWP) - class II
Orthosis, Spinal Pedicle Fixation - § 888.3070 (MNI) - class II
Orthosis, Spondylolisthesis Spinal Fixation - § 888.3070 (MNH) - class II
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
- § 888.3070 (NKB) - class III
All Orthopedic Device Panel 87 |
| Product Code: | KWP, KWQ, MNI, MNH & NKB |
| Device Description
and Characteristics: | 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. |
| Equivalence: | The Laguna™ Monoaxial Pedicle Screw System is substantially
equivalent to the Laguna™ (polyaxial) Pedicle Screw System, which is
manufactured and marketed by Allez Spine, LLC - K050060 S/E May 4,
2005 |
| Indications: | The Laguna Spinal 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. |
| Performance data: | Biomechanical tests have been performed. The test results were
equivalent to other similar implants and are sufficient for in vivo loading. |
1
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
2
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
3
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Page _________________________________________________________________________________________________________________________________________________________________________ of of
510(k) Number K051275
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