(15 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is intended to immobilize and stabilize spinal segments as an adjunct to fusion, treating conditions like degenerative disc disease, spondylolisthesis, fracture, and scoliosis, which are therapeutic applications.
No
Explanation: The ISSYS LP Spinal Fixation System is a medical implant used to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Its purpose is therapeutic (fixation), not diagnostic.
No
The device description clearly states it includes physical components like auxiliary connectors, rods, and screws, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system designed for the surgical fixation and stabilization of the spine. This is a physical intervention on the body.
- Device Description: The device description details physical components like screws, rods, and connectors, which are used in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
The device is a spinal fixation system, which is a type of implantable medical device used in surgery.
N/A
Intended Use / Indications for Use
The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolistlesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
The ISSYS LP Spinal Fixation System is also intended to provide immobilization and stabilization of the spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion of degenerative disc disease and spondylolisthesis other than severe spondylolisthesis (grade 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurological impairment.
When used as non pedicular fixation system:
The ISSYS LP Spinal Fixation System, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:
- Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Spondylolisthesis
- Fracture
- Spinal deformities such as scoliosis, kyphosis, lordosis
- Tumor
- Revision of failed fusion attempts
- Pseudoarthrosis
- Spinal Stenosis
When used in the anterior indication the ISSYS LP Spinal Fixation System is indicated for use in the thoracic and lumbar spine.
Product codes
NKB, KWP, MNI, MNH, KWQ
Device Description
The subject ISSYS LP Spinal Fixation System includes will include auxiliary connectors in the form of side to side, axial connectors, and offset connectors with various length arms up to 35mm. Additionally, pre bent 6.0 mm diameter rods, in various lengths, will be provided to be used with the side to side connectors, if required. These connectors are intended to be used with 5.5 mm, 6.0 mm, and 6.35 mm diameter rods. These additional components are to be used in the posterior non-cervical spine (T1-S1). The indications for use are not affected by the addition of these components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1), lumbar and/or sacral spine, L5-S1 joint, L3 and below, thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients
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)
Performance data per ASTM F1717 and F1798 were submitted to characterize the subject ISSYS LP Spinal Fixation system components in this notification.
Documentation is provided that the new component of the Custom Spine ISSSYS LP Spinal Fixation System is substantially equivalent to the predicate devices in terms of materials, mechanical properties, and indications for use. An engineering analysis and testing demonstrate meentined properies, and "Guidance for Spinal Systems 510(k)'s" Dated May 3, 2004 was completed for the ISSYS LP Spinal Fixation System, including the subject components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ISSYS LP Spinal Fixation System (K070281), ISSYS LP Spinal Fixation System (K072866), Moss Miami Spinal System (K933881), Moss Miami Spinal System (K955348), Moss Miami Spinal System (K964024), Moss Miami Spinal System (K983583), Moss Miami Spinal System (K022623), Optima Spinal System (K031585)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY - 5 2011
510(k) Summary
Name of Firm
Custom Spine, Incorporated 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone Number: (973) 808-0019 Fax Number: (973)-808-0707
Official Correspondent
Saad Attiyah Manager of Regulatory Affairs and Quality Assurance 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone Number: (973) 265-5036 Fax Number: (973)-808-0707 E-mail: saad@customspine.com
Establishment Number
3005129649
Device Name
Legally Market Trade Name: ISSYS LP Spinal Fixation System Common Name: Pedicle Screw System Device Classification: Class III Regulation Number: 21 CFR 888.3070 Device Product Codes: NKB, KWP, MNI, MNH, KWQ
Predicate Devices
ISSYS LP Spinal Fixation System (K070281, K072866) Moss Miami Spinal System (K933881, K955348, K964024, K983583, K022623) Optima Spinal System (K031585)
Description of Modified Device
The subject ISSYS LP Spinal Fixation System includes will include auxiliary connectors in the form of side to side, axial connectors, and offset connectors with various length arms up to 35mm. Additionally, pre bent 6.0 mm diameter rods, in various lengths, will be provided to be used with the side to side connectors, if required. These connectors are intended to be used with 5.5 mm, 6.0 mm, and 6.35 mm diameter rods. These additional components are to be used in the posterior non-cervical spine (T1-S1). The indications for use are not affected by the addition of these components.
1
Indications for Use
The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
For pedicular use: When used as pedicle screw fixation system of the non cervical posterior r or peareliar assort when matients, these systems are indicated for one or more of the following: decenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudoarthrosis).
In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with m automory wollisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
The ISSYS LP Spinal Fixation System is also intended to provide immobilization and stabilization of the spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion of degenerative disc disease and spondylolisthesis other than severe spondylolisthesis (grade 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurological impairment.
When used as non pedicular fixation system:
The ISSYS LP Spinal Fixation System, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:
- Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic . origin with degeneration of the disc confirmed by history and radiographic studies).
- Spondylolisthesis .
- Fracture .
- Spinal deformities such as scoliosis, kyphosis, lordosis .
- . Tumor
- Revision of failed fusion attempts .
- Pseudoarthrosis .
- Spinal Stenosis .
When used in the anterior indication the ISSYS LP Spinal Fixation System is indicated for use in the thoracic and lumbar spine.
Materials
Matchals are manufactured from ASTM F-136 implant grade titanium alloys.
Performance Data
Performance data per ASTM F1717 and F1798 were submitted to characterize the subject ISSYS LP Spinal Fixation system components in this notification.
Performance Data
Documentation is provided that the new component of the Custom Spine ISSSYS LP Spinal Fixation System is substantially equivalent to the predicate devices in terms of materials,
2
mechanical properties, and indications for use. An engineering analysis and testing demonstrate meentined properies, and "Guidance for Spinal Systems 510(k)'s" Dated May 3, 2004 was completed for the ISSYS LP Spinal Fixation System, including the subject components.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Custom Spine, Inc. % Mr. Saad Attiyah Manager of Regulatory Affairs/Quality Assurance 1140 Parsippany Boulevard. Suite 201 Parsippany. New Jersey 07054
MAY - 5 2011
Re: K111099
Trade/Device Name: ISSYS LP Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB. MNI. MNH. KWQ, KWP Dated: February 14, 2011 Received: April 20, 2011
Dear Mr. Attiyah:
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 (reporting of medical
4
Page 2 -- Mr. Saad Attivah
device-related adverse events) (21 CFR 803): 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHO1Tices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
A.S. Rte
ka
Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K111099 Device Name: ISSYS LP Spinal Fixation System
The ISSYS LP Spinal Fixation System is intended to help provide immobilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolistlesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
The ISSYS LP Spinal Fixation System is also intended to provide immobilization of the spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion of degenerative disc disease and spondylolisthesis other than severe spondylolisthesis (grade 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurological impairment.
When used as non pedicular fixation system:
The ISSYS LP Spinal Fixation System, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following.
- Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic • origin with degeneration of the disc confirmed by history and radiographic studies).
- Spondylolisthesis �
- Fracture �
- Spinal deformities such as scoliosis, kyphosis, lordosis .
- Tumor .
- Revision of failed fusion attempts .
- Pseudoarthrosis
- Spinal Stenosis
When used in the anterior indication the ISSYS LP Spinal Fixation System is indicated for use in the thoracic and lumbar spine.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| ------------------------------------------------- | --- |
AND/OROver-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
| KIII099 |
|---|
| 10(k) Number__________________________________________________________________________________________________________________________________________________________________ |