Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a spinal implant system and its indications for use. There is no mention of AI or ML technology in the intended use, device description, or performance studies.

Therapeutic

Yes
The device is a spinal system indicated for various spinal conditions, including degenerative spondylolisthesis, fractures, dislocations, scoliosis, kyphosis, spinal tumors, and failed fusions, all of which are medical conditions that the device aims to treat or alleviate.

Diagnostic

No

The device is a spinal system (implants) used for stabilization and correction of the spine, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device is comprised of implant components manufactured from stainless steel or titanium alloy, which are hardware materials. The submission is primarily focused on adding indications for pedicle screws, which are physical implants.

IVD (In Vitro Diagnostic)

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 surgical implant system used for stabilizing the spine in various conditions like spondylolisthesis, fracture, scoliosis, etc. This is a therapeutic device, not a diagnostic one.
Device Description: The description focuses on the materials and purpose of the implant components (spinal anchor, screws). This aligns with a surgical implant.
Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (blood, tissue, etc.) or providing information for diagnosis.
Performance Studies: The performance studies mentioned are related to the mechanical strength and fatigue of the implant constructs, which is typical for surgical devices.

Therefore, the Posterior and Anterior ISOLA Spinal Systems are surgical implants intended for therapeutic use, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

The Posterior ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion surgery.

The Anterior ISOLA system is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.

The Anterior ISOLA system is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include:

1. Collapsing and unstable paralytic deformity.
1. Progressively increasing scoliosis.
1. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
1. Inability to maintain sitting balance, necessitating the use of the hands.
1. Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
1. Spinal fractures (acute reduction or late deformity)
1. Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
1. Spinal tumor
1. Previous failed fusion surgery.

Spinal levels for Anterior ISOLA instrumentation are from T5-L4.

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

MNI, KWQ, KWP, MNH

Device Description

The primary purpose of this premarket notification is to add indications to the marketing clearance for the pedicle screws which may be used as a spinal anchor in the ISOLA Spine System.
All implant components are manufactured of either ASTM F-138 or F-1314 stainless steel or ASTM F-136 titanium alloy.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracic, lumbar, sacral spine, L5-S1, L3-S1, T1 to the ilium/sacrum, T5-L4

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)

Static and fatigue testing shows the constructs of the ISOLA Spinal System to perform consistently with previously cleared components.

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.

The ISOLA Spinal System manufactured from stainless steel or titanium alloy is substantially equivalent, for purposes of this 510(k) adding indications, to the Townley Screw previously marketed by Zimmer and the CD Spinal System currently marketed by Sofamor Danek.

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

Regulation Number and Section

§ 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.

Summary

0

OCT 21 1998

.

י יונים ש

:

ISOLA SPINAL SYSTEM Pedicle Screw Indications 510(k) SUMMARY

| COMPANY: | DePuy AcroMed, Inc.
3303 Carnegie Avenue
Cleveland, OH 44115 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TRADENAME: | ISOLA Spinal System |
| CLASSIFICATION: | Labeled for pedicle screw use: Class II
Labeled for previously cleared uses: Class II
Spinal interlaminal fixation orthosis: Class II |
| DESCRIPTION: | The primary purpose of this premarket notification is to add
indications to the marketing clearance for the pedicle screws which
may be used as a spinal anchor in the ISOLA Spine System. |
| MATERIAL: | All implant components are manufactured of either ASTM F-138 or
F-1314 stainless steel or ASTM F-136 titanium alloy. |
| INDICATIONS: | The Posterior ISOLA Spinal System, when used with pedicle
screws, is indicated for degenerative spondylolisthesis with
objective evidence of neurologic impairment, fracture, dislocation,
scoliosis, kyphosis, spinal tumor, and failed previous fusion
(pseudarthrosis). Levels of fixation are for the thoracic, lumbar
and sacral spine.
The Posterior ISOLA Spinal System is also indicated for pedicle
screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-
S1, in skeletally mature patients, when autogenous bone graft is
used, when affixed to the posterior lumbosacral spine, and intended
to be removed after solid fusion is attained. Levels of fixation are
from L3-S1.
The Posterior ISOLA Spinal System, when not used with pedicle
screws, is intended for hook, wire, and/or sacral/iliac screw fixation |

1

spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion surgery.

The Anterior ISOLA system is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.

The Anterior ISOLA system is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include:

1. Collapsing and unstable paralytic deformity.
1. Progressively increasing scoliosis.
1. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
1. Inability to maintain sitting balance, necessitating the use of the hands.
1. Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
1. Spinal fractures (acute reduction or late deformity)
1. Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
1. Spinal tumor
1. Previous failed fusion surgery.

Spinal levels for Anterior ISOLA instrumentation are from T5-L4.

PERFORMANCE DATA:

Static and fatigue testing shows the constructs of the ISOLA Spinal System to perform consistently with previously cleared components.

2

SUBSTANTIAL EQUIVALENCE:

The ISOLA Spinal System manufactured from stainless steel or titanium alloy is substantially equivalent, for purposes of this 510(k) adding indications, to the Townley Screw previously marketed by Zimmer and the CD Spinal System currently marketed by Sofamor Danek.

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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 21 1998

Mr. William Christianson Vice President. Regulatory Affairs DePuy AcroMed, Inc. 3303 Carnegie Avenue Cleveland, Ohio 44115

K980485 Trade Name: ISOLA Spinal System Regulatory Class: II Product Codes: MNI, KWQ, KWP, and MNH Dated: August 20, 1998 Received: August 24, 1998

Dear Mr. Christianson:

Re:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

4

Page 2 - Mr. William Christianson

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

Page 1 of 2

510(k) Number (if known):

Device Name: ISOLA Spine System (Titanium and Stainless Steel)

Indications for Use:

The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

The Posterior ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion surgery.

Continued on next page

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	KC980485

Prescription Use (Per 21 CFR 801.109)	X	OR	Over-The-Counter Use
---------------------------------------	---	----	----------------------

(Optional Format 1-2-96)

6

Page 2 of 2

510(k) Number (if known):

Device Name: ISOLA Spine System (Titanium and Stainless Steel)

Indications for Use:

The Anterior ISOLA system is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.

The Anterior ISOLA system is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include:

1. Collapsing and unstable paralytic deformity.
Progressively increasing scoliosis. 2.
Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse. 3.
Inability to maintain sitting balance, necessitating the use of the hands. ধ .
Increasing pelvic obliquity coincident with back pain or loss of sitting balance. 5.
Spinal fractures (acute reduction or late deformity) 6.
Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc 7. confirmed by history and radiographic studies).
1. Spinal tumor
1. Previous failed fusion surgery.

Spinal levels for Anterior ISOLA instrumentation are from T5-L4.

Prescription Use
(Per 21 CFR 801.109)

Division Sign Off

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K-980485