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K Number
K132280
Device Name
ALTUS SPINE PEDICLE SCREW SYSTEM
Manufacturer
ALTUS PARTNERS
Date Cleared
2013-10-31

(100 days)

Product Code
MNIKWPKWQMNH
Regulation Number
888.3070
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Altus Spine Pedicle Screw System is a noncervical spinal fixation device intended to provide stabilization of the spinal segments. It is indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft only having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the Altus Spine Pedicle Screw System may be used 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: 1. Degenerative Spondylolisthesis with objective evidence of neurologic impairment; 2. Fracture; 3. Dislocation; 4. Scoliosis; 5. Kyphosis; 6. Spinal Tumor; 7. Failed previous fusion (pseudoarthrosis). When used as a non-posterior, non-pedicle anterolateral fixation system the specific indications are: 1. Degenerative disc disease as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; 2. Spondylolisthesis; 3. Fracture; 4. Dislocation; 5. Scoliosis; 6. Kyphosis; 7. Lordosis; 8. Spinal stenosis; 9. Spinal tumor; 10. Failed previous fusion (pseudoarthrosis)
Device Description
The Altus Spine Pedicle Screw System consists of a system of implantable screws to be used with implantable rods for the purpose of aiding in spinal fusion. The Altus Spine Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136. The device is supplied non-sterile and is intended for sterilization by hospital personal.
More Information

K033352, K043152, K051716, K071376, K081597

Not Found

No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.

Yes
The device is intended to provide stabilization of spinal segments and aid in spinal fusion for various acute and chronic instabilities or deformities, which are therapeutic actions.

No

Explanation: The Altus Spine Pedicle Screw System is a surgical implant designed to provide stabilization and immobilization of spinal segments, aiding in spinal fusion. It is a treatment device, not a diagnostic one.

No

The device description explicitly states that the system consists of "implantable screws to be used with implantable rods" and that these components are made of "titanium alloy." This clearly indicates the device is a hardware-based medical device, not software-only.

No, 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: The Altus Spine Pedicle Screw System is described as a system of implantable screws and rods used for spinal fixation and stabilization during spinal fusion surgery.
  • Intended Use: The intended use clearly states it's for providing stabilization of spinal segments and is an adjunct to fusion. This is a surgical intervention, not a diagnostic test performed on a sample.

The device is a surgical implant used directly within the body, not a tool for analyzing biological samples outside the body.

N/A

Intended Use / Indications for Use

The Altus Spine Pedicle Screw System is a noncervical spinal fixation device intended to provide stabilization of the spinal segments. It is indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft only having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Altus Spine Pedicle Screw System may be used 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:

    1. Degenerative Spondylolisthesis with objective evidence of neurologic impairment;
    1. Fracture;
    1. Dislocation;
  • Scoliosis;
    1. Kyphosis;
    1. Spinal Tumor;
    1. Failed previous fusion (pseudoarthrosis).

When used as a non-posterior, non-pedicle anterolateral fixation system the specific indications are:

    1. Degenerative disc disease as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
    1. Spondylolisthesis:
    1. Fracture;
  • Dislocation;
    1. Scoliosis;
  • Kyphosis; 6.
    1. Lordosis;
    1. Spinal stenosis;
  • Spinal tumor; g.
    1. Failed previous fusion (pseudoarthrosis)

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

MNI, MNH, KWQ, KWP

Device Description

The Altus Spine Pedicle Screw System consists of a system of implantable screws to be used with implantable rods for the purpose of aiding in spinal fusion. The Altus Spine Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136. The device is supplied non-sterile and is intended for sterilization by hospital personal.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Spinal segments, fifth lumbar-first sacral (L5-S1) vertebral joint, lumbar and sacral spine (L3 to sacrum), 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)

Dynamic compression bending, static compression bending, and static torsion testings were completed per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy model. All mechanical testing met the predetermined acceptance criteria.

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.

K033352, K043152, K051716, K071376, K081597

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.

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OCT 3 1 2013

4. 510(k) Summary

SUBMITTER:Altus Partners
5129 West Chester Pike
Newtown Square, PA 19073
Phone: 610-355-4156
Fax: 610-300-3049
CONTACT PERSON:Claudia Hill
Product Development Engineer
DATE PREPARED:October 30, 2013
COMMON NAME:Pedicle Screw Spinal System
PROPRIETARY NAME:Altus Spine Pedicle Screw System
PREDICATE DEVICES:Vertebron PSS Pedicle Screw System (K033352, K043152, K051716,
K071376, & K081597)
CLASSIFICATION NAME:21 CFR §888.3050 Spinal Interlaminal Fixation Orthosis
21 CFR §888.3060 Spinal Intervertebral Fixation Orthosis
21 CFR §888.3070 Pedicle Screw Spinal System
PRODUCT CODES:MNI, MNH, KWQ, and KWP
DEVICE CLASS:Class II

DEVICE DESCRIPTION:

The Altus Spine Pedicle Screw System consists of a system of implantable screws to be used with implantable rods for the purpose of aiding in spinal fusion. The Altus Spine Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct with the intent to stabilize the spinal operative site during the fusion process of bone graft in the disc space. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136. The device is supplied non-sterile and is intended for sterilization by hospital personal.

INDICATIONS FOR USE:

The Altus Spine Pedicle Screw System is a noncervical spinal fixation device intended to provide stabilization of the spinal segments. It is indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft only having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Altus Spine Pedicle Screw System may be used 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:

    1. Degenerative Spondylolisthesis with objective evidence of neurologic impairment;
    1. Fracture;
    1. Dislocation;
    1. Scoliosis;
  • ഗ് Kyphosis;
  • Spinal Tumor; 6.
    1. Failed previous fusion (pseudoarthrosis).

1

When used as a non-posterior, non-pedicle anterolateral fixation system the specific indications are:

  • Degenerative disc disease as defined by chronic back pain of discogenic origin with 1. degeneration of the disc confirmed by history and radiographic studies;
    1. Spondylolisthesis;
    1. Fracture;
    1. Dislocation;
    1. Scoliosis;
    1. Kyphosis;
  • Lordosis; 7.
    1. Spinal stenosis;
    1. Spinal tumor;
    1. Failed previous fusion (pseudoarthrosis)

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The intended use, technological principles, and material of the Altus Spine Pedicle Screw System do not substantially differ from the predicate devices. Cleaning and sterilizating is done in the same manner, and both provide correction and stability during the fusion process of bone fusion. Device samples underwent testing and had comparable performance and function when compared to the predicate device.

SUMMARY OF NON-CLINAL TESTS SUBMITTED:

Dynamic compression bending, static compression bending, and static torsion testings were completed per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy model. All mechanical testing met the predetermined acceptance criteria.

SUBSTANTIAL EQUIVALENCE CONCLUSION:

Testing in accordance with ASTM F1717 was performed and demonstrated that the Altus Spine Pedicle Screw System is substantially equivalent to the currently marketed Vertebron PSS Pedicle Screw System (K033352, K043152, K051716, K071376, & K081597).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping human figures.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 31, 2013

Altus Partners. LLC Ms. Claudia Hill Product Development Engineer 5129 West Chester Pike Newtown Square, Pennsylvania 19073

Re: K132280

Trade/Device Name: Altus Spine Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP, KWP, KWQ Dated: August 9, 2013 Received: August 12, 2013

Dear Ms. Hill:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

3

Page 2 - Ms. Claudia Hill

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

3. Indications for Use Statement

Indications for Use

510(k) Number (if known): K132280 Device Name: Altus Spine Pedicle Screw System Indications for Use:

The Altus Spine Pedicle Screw System is a noncervical spinal fixation device intended to provide stabilization of the spinal segments. It is indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft only having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Altus Spine Pedicle Screw System may be used 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:

    1. Degenerative Spondylolisthesis with objective evidence of neurologic impairment;
    1. Fracture;
    1. Dislocation;
  • ধে Scoliosis;
    1. Kyphosis;
    1. Spinal Tumor;
    1. Failed previous fusion (pseudoarthrosis).

When used as a non-posterior, non-pedicle anterolateral fixation system the specific indications are:

    1. Degenerative disc disease as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies;
    1. Spondylolisthesis:
    1. Fracture;
  • ধ Dislocation;
    1. Scoliosis;
  • Kyphosis; 6.
    1. Lordosis;
    1. Spinal stenosis;
  • Spinal tumor; g.
    1. Failed previous fusion (pseudoarthrosis)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) an -S Division of Orthopedic Devices 510(k) Number: K132280