The VIPER Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The VIPER Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients. With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the VIPER Spine System may be used for the aforementioned indications in skeletally mature patients.

The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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 failed previous fusion in skeletally mature patients. With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the EXPEDIUM Spine System may be used for the aforementioned indications in skeletally mature patients.

Device Description

This submission addresses additional rod components. Rod components are manufactured from medical grade PEEK (polyetheretherketone) polymer both with and without 6% barium sulfate (BaSO4) filler and ASTM F 560 implant grade tantalum wire. Setscrew components are manufactured from ASTM F 136 implant grade titanium alloy.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the VIPER™ and EXPEDIUM™ Spine Systems:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Reported Device Performance (VIPER™ & EXPEDIUM™ Spine Systems)
Material Composition	Rod components: Medical-grade PEEK (polyetheretherketone) polymer (with and without 6% barium sulfate (BaSO4) filler) and ASTM F 560 implant grade tantalum wire. Setscrew components: ASTM F 136 implant grade titanium alloy.
Mechanical Performance	Performance data per ASTM F 1717 and ASTM F 1798.
Biocompatibility	Not explicitly stated as an acceptance criterion or performance measure within the provided text, but implied by the use of "medical grade" materials and general regulatory standards for implants.
Sterility	Not explicitly stated as an acceptance criterion or performance measure within the provided text.
Shelf Life/Stability	Not explicitly stated as an acceptance criterion or performance measure within the provided text.

Study Information

Based on the provided text, the submission is a "Traditional 510(k) Submission" for additional rod components for existing spine systems. The regulatory review focuses on substantial equivalence to predicate devices. This type of submission typically relies heavily on performance data from recognized standards rather than extensive clinical studies with human participants.

Here's a breakdown of the study-related information:

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of human data. The performance data provided is for material and mechanical testing using ASTM standards. The sample sizes for these specific tests (e.g., number of rods tested, number of cycles) are not detailed in the provided summary.
- Data Provenance: Not applicable in the context of human data. The performance data is derived from in-vitro mechanical testing according to established ASTM standards. The country of origin for such laboratory testing is not specified but is typically performed by the manufacturer or a certified testing lab. It is a retrospective analysis of device performance against standards.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The "ground truth" for this device, in terms of its substantial equivalence, is based on its compliance with established mechanical standards (ASTM F 1717 and ASTM F 1798) and material specifications. There is no explicit mention of human experts establishing "ground truth" for a test set in the way one would for diagnostic imaging.
- The "experts" involved are the engineers and material scientists who designed and tested the device, and the regulatory bodies (like FDA) who evaluate compliance with standards.
Adjudication Method for the Test Set:
- Not applicable. This device relies on objective, quantifiable mechanical and material testing against established standards, not subjective interpretations requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The provided documentation does not indicate that a MRMC comparative effectiveness study was done. This type of study is more common for diagnostic devices where human interpretation of data (e.g., medical images) is central. For an orthopedic implant like a spinal rod, the focus is on mechanical integrity and material properties.
- Effect Size: Not applicable, as no such study was conducted.
Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
- Yes, in spirit. The performance data submitted is for the device itself (the rods and setscrews) independent of human-in-the-loop performance. Its mechanical properties and material composition are characterized in a "standalone" fashion against engineering standards.
- However, this is not an "algorithm" in the typical sense of AI/software performance. It's the physical device's performance.
Type of Ground Truth Used:
- Engineering Standards and Material Specifications: The "ground truth" for the device's performance is compliance with established ASTM (American Society for Testing and Materials) standards: ASTM F 1717 ("Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model") and ASTM F 1798 ("Standard Guide for Evaluation of Spinal Intervertebral Body Fusion Devices in vitro"). Additionally, material "ground truth" is based on medical-grade PEEK and titanium alloys meeting specific ASTM F 560 and ASTM F 136 standards.
Sample Size for the Training Set:
- Not applicable. This submission concerns a physical implant, not a machine learning algorithm that requires a "training set."
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for a machine learning model.

Summary

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Traditional 510(k) Submission -- VIPERTM and EXPEDIUM™ PB

5. 510(K) SUMMARY

510(k) Summary - VIPERTM Spine System 5.1.

Submitter:	DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767
------------	---------------------------------------------------------------

MAY 15 2008

Contact Person:	Christopher Klaczyk
	Regulatory Project Manager
Voice:	(508) 828-2852
Fax:	(508) 828-3797
E-Mail:	cklaczyk@dpyus.jnj.com

February 21, 2008 Date Prepared:

Device Class: Class III
Classification Name: Pedicle screw spinal fixation per 21 CFR §888.3070

Spinal interlaminar fixation orthosis per 21 CFR §888.3050

Spinal intervertebral body fixation orthosis per 21 CFR §888.3060

Classification Panel: Orthopedics

FDA Panel Number: 87

Product Code(s):	NKB, MNI, MNH, KWP, KWQ
------------------	-------------------------

Proprietary Name: VIPERTM Spine System

CD HORIZON® Legacy Spinal System (Medtronic Predicate Devices: Sofamor Danek: K050809, K063670) VIPER Spine System (K041801, K071860) MOSS Miami Spine System (K011182)

Device Description: This submission addresses additional rod components.

The VIPER Spine System is intended to provide Intended Use: immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

ﯿ

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The VIPER Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the VIPER Spine System may be used for the aforementioned indications in skeletally mature patients.

Materials: Rod components are manufactured from medical grade PEEK (polyetheretherketone) polymer both with and without 6% barium sulfate (BaSO4) filler and ASTM F 560 implant grade tantalum wire. Setscrew components are manufactured from ASTM F 136 implant grade titanium allov.
Performance Data: Performance data per ASTM F 1717 and ASTM F 1798 were submitted to characterize the subject spine system components addressed in this notification.

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Traditional 510(k) Submission – VIPER™ and EXPEDIUM™ PEEK Rods

5.2. 510(k) Summary - EXPEDIUM™ Spine System

Submitter:	DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767
Contact Person:	Christopher KlaczykRegulatory Project ManagerVoice: (508) 828-2852Fax: (508) 828-3797E-Mail: cklaczyk@dpyus.jnj.com
Date Prepared:	February 21, 2008
Device Class:	Class III
Classification Name:	Pedicle screw spinal fixation per 21 CFR §888.3070Spinal interlaminar fixation orthosis per 21 CFR §888.3050Spinal intervertebral body fixation orthosis per 21 CFR §888.3060
Classification Panel:	Orthopedics
FDA Panel Number:	87
Product Code(s):	NKB, MNI, MNH, KWP, KWQ
Proprietary Name:	EXPEDIUM™ Spine System
Predicate Devices:	CD HORIZON® Legacy Spinal System (MedtronicSofamor Danek; K050809, K063670)EXPEDIUM Spine System (K033901, K062174)MOSS Miami Spine System (K011182)
Device Description:	This submission addresses additional rod components

The EXPEDIUM Spine System is intended to provide Intended Use: immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

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	The EXPEDIUM Spine System is intended for noncervicalpedicle fixation and nonpedicle fixation for the followingindications: degenerative disc disease (defined as back painof discogenic origin with degeneration of the discconfirmed by history and radiographic studies);spondylolisthesis; trauma (i.e., fracture or dislocation);spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/orlordosis); tumor; pseudarthrosis; and failed previous fusionin skeletally mature patients.
	With the exception of degenerative disc disease (DDD), thePEEK rods and associated components of the EXPEDIUMSpine System may be used for the aforementionedindications in skeletally mature patients.
Materials:	Rod components are manufactured from medical gradePEEK (polyetheretherketone) polymer both with andwithout 6% barium sulfate (BaSO4) filler and ASTM F 560implant grade tantalum wire. Setscrew components aremanufactured from ASTM F 136 implant grade titaniumalloy.
Performance Data:	Performance data per ASTM F 1717 and ASTM F 1798were submitted to characterize the subject spine systemcomponents addressed in this notification.

DePuy Spine, Inc., a Johnson & Johnson Company

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 15 2008

DePuy Spine % Mr. Christopher Klaczyk Regulatory Project Manager 325 Paramount Drive Raynham, MA 02767

Re: K073562

Trade/Device Name: VIPER™ and EXPEDIUM™M Spine Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH Dated: May 12, 2008 Received: May 13, 2008

Dear Mr. Klaczyk:

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 – Mr. Christopher Klaczyk

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 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 M. 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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4. INDICATIONS FOR USE STATEMENT 4.1. INDICATIONS FOR USE STATEMENT - VIPER SPINE SYSTEM

510(k) Number (if known): K073562

Device Name: VIPERTM Spine System

Indications For Use:

The VIPER Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the VIPER Spine System may be used for the aforementioned indications in skeletally mature patients.

Prescription Use ﻷ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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)
Division of General, Restorative,
and Neurological Devices
	Page
DePuy Spine, Inc., a Johnson & Johnson Company
510(k) Number	K073562
	Page 4-1

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INDICATIONS FOR USE STATEMENT - EXPEDIUM SPINE 4.2. SYSTEM

510(k) Number (if known): K073562

Device Name: EXPEDIUM™ Spine System

Indications For Use:

The EXPEDIUM™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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 failed previous fusion in skeletally mature patients.

With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the EXPEDIUM Spine System may be used for the aforementioned indications in skeletally mature patients.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

NihleO, for mxn

Division of General, Restorative. and Neurological Devices

Page 1 of 1

ohnson & Johnson Company

Page 4-2

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.