(43 days)
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The PILOT® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
When used as a posterior spine thoracic/lumbar system, the PILOT® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis). (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
When implanted in the thoracic, lumbar, and/or sacral spine, the PILOT® Spinal System provides additional support during spinal fusion. The PILOT® Spinal System consists of screws and rods in a variety of shapes and sizes. The PILOT® Spinal System is manufactured from medical grade titanium alloy and will be sold non-sterile.
This document (K080502) is a 510(k) summary for the PILOT® Spinal System by Life Spine. It indicates that the device was found substantially equivalent to previously cleared devices.
Based on the provided text, there is no acceptance criteria or study information related to device performance, AI/algorithm efficacy, sample sizes, ground truth establishment, or expert adjudication.
The document primarily focuses on:
- Device Description: The PILOT® Spinal System consists of screws and rods made of medical grade titanium alloy for posterior pedicle screw fixation.
- Intended Use: Provides additional support during spinal fusion in the thoracic, lumbar, and/or sacral spine for skeletally mature patients to stabilize and immobilize spinal segments. Indications include degenerative disc disease, trauma, curvatures, spinal tumor, failed previous fusion, pseudarthrosis, spinal stenosis, and spondylolisthesis.
- Substantial Equivalence: The device was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used. This is a common regulatory pathway for medical devices where extensive clinical outcome studies (as would be required for novel AI devices) are often not necessary if equivalence to a predicate device can be demonstrated.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies because it is not present in the given text. This type of 510(k) submission generally relies on demonstrating equivalence to an existing device rather than presenting novel performance study data against specific quantitative acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. A curved line is located underneath the word "Spine". The registered trademark symbol is located to the right of the word "Spine".
080502
510(k) Summary
PILOT® Spinal System
APR - 8 2008
Submitted By: Life Spine 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118
Rebecca Brooks Life Spine 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118
Date Prepared:
510(k) Contact:
Trade Name:
Common Name:
Classification:
Pedicle screw spinal system
PILOT® Spinal System
February 22, 2008
21 CRF 888.3070 Pedicle Screw Spinal System
Device Product Code:
MNI: Orthosis, Spinal, Pedicle Fixation MNH: Orthosis, spondylolisthesis spinal fixation
Device Description:
When implanted in the thoracic, lumbar, and/or sacral spine, the PILOT® Spinal System provides additional support during spinal fusion. The PILOT® Spinal System consists of screws and rods in a variety of shapes and sizes. The PILOT® Spinal System is manufactured from medical grade titanium alloy and will be sold non-sterile.
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Image /page/1/Picture/1 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. A curved line appears below the word "Spine", emphasizing the spine. The logo is simple and modern.
Intended Use of the Device:
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The PILOT® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
When used as a posterior spine thoracic/Jumbar system, the PILOT® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis). (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
Substantial Equivalence:
The PILOT® Spinal System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Life Spine % Ms. Rebecca M. Brooks 2401 W. Hassel Road Suite 1535 Hoffman Estates, IL 60169
APR - 8 2008
Re: K080502
Trade/Device Name: Pilot Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI. MNH Dated: April 1, 2008 Received: April 2, 2008
Dear Ms. Brooks:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Ms. Rebecca M. Brooks
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 marketed predicate device results in 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millman
Mark N. Melkerson 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: PILOT® Spinal System
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The PILOT® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.
When used as a posterior spine thoracic/lumbar system, the PILOT® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
Prescription Use _ x _ (Part 21 CFR 801 Subpart D)
And/Or
Over-the-Counter Use (21 CFR 807 Subpart C)
UTX
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Neil RP Ogde
(Division Sign-Off) for
Division of General, Restorative. and Neurological Devices
510(k) Number K080502
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