The PISCES™ SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

· PISCESTM-SA Used With Screws:

When used with three (3) screws, interbody devices with a lordotic angle < 20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels.

Hyperlordotic interbody devices (>20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.

· PISCESTM_SA Used With Anchors

When used with three (3) anchors, these devices can be used as interbody fusion devices at 1 or 2 levels and must always be used with supplemental fixation.

PISCESTM ALIF Spacers (Without Integrated Fixation)

PISCESTM ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudatthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (200 lordosis) must be used with at least anterior supplemental fixation.

Device Description

PISCES™-SA Standalone ALIF Interbody System is an interbody fusion device for the lumbar spine that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws, these devices are standalone interbody fusion devices. When used with anchors or without screws, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The PISCES" -SA interbodies are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The spacers are available in multiple sizes. The spacers are single use devices, which are sterilized via gamma radiation and are provided to the user in sterile packages. The screws, anchors, and locking plates are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and must be sterilized prior to use. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use. The screws, anchors, locking plates, and instruments are supplied in a re-usable tray for steam sterilization.

AI/ML Overview

The provided text does not contain information about specific acceptance criteria, study details, or performance results from a clinical or analytical study. The document is primarily a 510(k) submission summary for a medical device (PISCES™-SA Standalone ALIF Interbody System), demonstrating substantial equivalence to predicate devices through non-clinical testing.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies. The text explicitly states "Substantial equivalence is supported by the results of mechanical testing," and "Substantial equivalence is also supported by performing cadaveric implantation and cadaveric Range of Motion (ROM) studies." This indicates that the safety and effectiveness determination for this device was based on non-clinical data rather than human clinical trials.

The information I can extract about the testing performed is:

Non-clinical Testing Performed:

Static and dynamic compression per ASTM F2077
Static and dynamic compression shear per ASTM F2077
Subsidence per ASTM F2267
Expulsion testing
Cantilever anchor bending
Anchor impaction testing
Cadaveric implantation
Cadaveric Range of Motion (ROM) studies

Since the request asks for details that are typically associated with clinical or analytical studies involving human data or expert review for AI/ML devices, and this document pertains to a spinal implant cleared through substantial equivalence based on non-clinical data, the majority of the requested fields cannot be filled.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 6, 2022

Osseus Fusion Systems % Daniel Johnson Regulatory Engineer Jalex Medical LLC 27865 Clemens Rd Suite 3 Westlake, Ohio 44145

Re: K213935

Trade/Device Name: PISCES™-SA Standalone ALIF Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX, PHM

Dear Daniel Johnson:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 6, 2022. Specifically, FDA is updating this SE Letter to correct the product code as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, (240) 402-1840, Brent.Showalter@fda.hhs.gov.

Sincerely,

Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized depiction of a human figure, while the FDA portion includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font and "ADMINISTRATION" in a smaller font below.

May 6, 2022

Osseus Fusion Systems % Daniel Johnson Regulatory Engineer Jalex Medical LLC 27865 Clemens Rd Suite 3 Westlake, Ohio 44145

Re: K213935

Dear Daniel Johnson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brent Showalter -S

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213935

Device Name PISCESTM_SA Standalone ALIF Interbody System

Indications for Use (Describe)

PISCESTM-SA ALIF Spacers (Standalone Use. With Integrated Fixation)

· PISCESTM-SA Used With Screws:

When used with three (3) screws, interbody devices with a lordotic angle < 20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels.

Hyperlordotic interbody devices (>20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.

· PISCESTM_SA Used With Anchors

When used with three (3) anchors, these devices can be used as interbody fusion devices at 1 or 2 levels and must always be used with supplemental fixation.

PISCESTM ALIF Spacers (Without Integrated Fixation)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/5/Picture/0 description: The image shows the logo for OSSEUS. The logo is in a gradient of purple and blue. The logo consists of a square with a circle inside of it, followed by the text "OSSEUS" in a sans-serif font. The letters are in a gradient of purple and blue, with the left side of the letters being purple and the right side being blue.

510(k) Summary

Submitted By:	Osseus Fusion Systems1931 Greenville Ave.Suite 200Dallas, TX 75206
Date:	12/14/21
Contact Person:Contact Telephone:Contact Fax:	Daniel Johnson, Regulatory Engineer(440) 541-0060(440) 933-7839
Device Trade Name:Device Classification Name:Device Classification:Reviewing Panel:Product Code:Predicate Device:Additional Predicates:	PISCESTM-SA STANDALONE ALIF Interbody SystemIntervertebral Body Fusion Device with Integrated Fixation, LumbarClass IIOrthopedicOVD, MAX, PHMK191391 - Globus HEDRON Lumbar SpacersK181347 - Osseus ARIES Lumbar InterbodiesK153495 - Zimmer ROI-A ALIF Cage SystemK203742 - Alphatec IdentiTiTM ALIF Standalone Interbody SystemK192121 - Black Diamond Pedicle Screw System

The predicate devices have not been subject to any design related recalls.

Device Description:

Intended Use:

PISCESTM-SA ALIF Spacers (Standalone Use, With Integrated Fixation)

The PISCES™-SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and

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have had at least six (6) months of non-operative treatment. PISCES™-SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

o PISCES™-SA Used With Screws:
When used with three (3) screws, interbody devices with a lordotic angle ≤ 20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels.

Hyperlordotic interbody devices (>20° lordosis) used with screws, must always be used with supplemental fixation, and may be used at 1 or 2 levels.

PISCESTM-SA Used With Anchors ● When used with three (3) anchors, these devices can be used as interbody fusion devices at 1 or 2 levels and must always be used with supplemental fixation.

PISCESTM ALIF Spacers (Without Integrated Fixation)

PISCES™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.

Summary of Technological Characteristics:

PISCES™-SA Standalone ALIF Interbody System and the predicates have the same intended use and fundamental scientific technology. All devices compare similarly in:

Design features ●
Intended use ●
. Materials
Dimensions ●
Function .

Please see Table 1 Below for a comparison of the devices. The Globus HEDRON information was gathered from the system's surgical technique and marketing information.

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Summary of Technological Characteristics

'able 1: Technological Characteristics Comparison

Feature	Subject Device: PISCESTM-SA Standalone ALIF Interbody System	Primary Predicate: K191391-Globus HEDRON Lumbar Spacers	Comparison
Regulation	888.3080	888.3080	Equivalent
Product Code	OVD, MAX, PHM	MAX, OVD, PHM	Equivalent
Indications for Use	PISCESTM-SA ALIF Spacers(Standalone Use, With Integrated Fixation)The PISCESTM-SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCESTM-SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.	HEDRONTM Lumbar Spacers(HEDRON ATM, HEDRON LTM, HEDRON PTM, HEDRON TTM, and HEDRON RTTM) are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. HEDRONTM Spacers	Equivalent
• PISCESTM-SA Used WithScrews:When used with three (3)screws, interbody deviceswith a lordotic angle ≤20° can be used asstandalone interbodyfusion devices at 1 or 2contiguous levels.	are to be filled with autograftbone and/or allogenic bone graftcomposed of cancellous and/orcorticocancellous bone. Thesedevices are intended to be usedwith supplemental fixationsystems that have been clearedfor use in the thoracolumbosacralspine (e.g., posterior pediclescrew and rod systems, anteriorplate systems, and anterior screwand rod systems). Hyperlordoticinterbody devices (≥20° lordosis)must be used with at least anteriorsupplemental fixation.	HEDRON IAT™ IntegratedLumbar Spacers are integratedlumbar interbody fusion devicesintended for use in patients withdegenerative disc disease (DDD)at one or two contiguous levels ofthe lumbosacral spine (L2-S1).DDD is defined as discogenicback pain with degeneration ofthe disc confirmed by history andradiographic studies. Thesepatients should be skeletallymature and have had at least six(6) months of non-operativetreatment. In addition, thesepatients may have up to Grade 1spondylolisthesis or retrolisthesisat the involved level(s).HEDRON IAT™ Spacers are to befilled with autograft bone and/or
Hyperlordotic interbodydevices (>20° lordosis)used with screws, mustalways be used withsupplemental fixation,and may be used at 1 or 2levels.
• PISCESTM-SA Used WithAnchors
When used with three (3)anchors, interbodydevices with a lordoticangle ≤ 20° can be usedas standalone interbodyfusion devices at 1 or 2levels.
Hyperlordotic interbodydevices (>20° lordosis)used with anchors, mustalways be used withsupplemental fixation,
allogenic bone graft composed ofcancellous and/or	PISCESTM ALIF Spacers(Without Integrated Fixation)PISCESTM ALIF Spacers arelumbar interbody fusion devicesindicated at one or more levels ofthe thoracic spine (T1-T12),thoracolumbar junction (T12-L1),or lumbosacral spine (L1-S1) asan adjunct to fusion in patientswith the following indications:degenerative disc disease (DDD),disc herniation (with myelopathyand/or radiculopathy),spondylolisthesis, deformity(degenerative scoliosis orkyphosis), spinal stenosis, andfailed previous fusion(pseudarthrosis). DDD is definedas discogenic back pain withdegeneration of the disc asconfirmed by history andradiographic studies. Thesepatients should be skeletallymature and have had at least six(6) months of non-operativetreatment. PISCESTM ALIFSpacers are to be filled withautograft bone and/or allogenicbone graft composed ofcancellous and/orcorticocancellous bone. Thesedevices are intended to be usedwith supplemental fixationsystems that have been clearedand may be used at 1 or 2levels.	corticocancellous bone. Thesedevices are intended to be usedwith three screws or anchorswhich accompany the implants.When used with screws, thesedevices are stand-alone interbodyfusion devices. When used withanchors, these devices areintended for use withsupplemental fixation (e.g. facetscrews or posterior fixation).Hyperlordotic implants (≥25°lordosis) are intended for use withsupplemental fixation (e.g. facetscrews or posterior fixation).When used without screws oranchors, these devices areintended for use withsupplemental fixation (e.g. facetscrews or posterior fixation).

Page 3 of 8

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ම් ග්‍රිය පිටි කිරීම ප්‍රධාන අවස්ථාන මිත කිරීම සිට පිහිටි මිත කිරීම සිට පිහිටි මිත කිරීම පිහිටි මිත කිරීම පිහිටි මිත කිරීම පිහිටි මිත කිරීම පිහිටි මිත කිරීම පිහිටි මිත කිරීම

Page 4 of 8

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ම් ග්‍රිය පිහිටි පිහිටි පිහිටි බව පිහිටි පිහිටි පිහිටි බව පිහිටි පිහිටි බව පිහිටි පිහිටි පිහිටි බව පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි පිහිටි මිනිස් පිහිටි මිනිස් පිහි

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	for use in the thoracolumbosacralspine (e.g., posterior pediclescrew and rod systems, anteriorplate systems, and anterior screwand rod systems). Hyperlordoticinterbody devices (≥20° lordosis)must be used with at least anteriorsupplemental fixation.
Device Description	PISCESTM-SA Standalone ALIFspacers are interbody fusiondevices for the lumbar spine thatmay be used with three titaniumalloy screws or anchors whichaccompany the implants. Whenused with screws and/or anchors,these devices are standaloneinterbody fusion devices. Whenused without screws and/oranchors, these devices areintended for use withsupplemental fixation (e.g. facetscrews or posterior fixation). ThePISCESTM-SA spacers aremanufactured from titanium alloy(Ti-6Al-4V ELI) per ASTMF3001. The spacers are availablein multiple sizes. The spacers aresingle use devices, which aresterilized via gamma radiationand are provided to the user insterile packages. The screws,anchors, and locking plates aremanufactured from titanium alloy(Ti-6Al-4V ELI) per ASTM F136	HEDRON Integrated LumbarSpacers are integrated anteriorlumbar interbody fusion devicesused to provide structural stabilityfollowing discectomy. They areused with screws and/or anchors.All HEDRON Lumbar Spacersare additively manufactured fromtitanium powder per ASTMF3001. The mating screws andanchors are manufactured fromtitanium alloy, per ASTM F135and F1295, and/or cobalt chromealloy, per ASTM F1567.Titanium screws and anchors areavailable with or withouthydroxyapatite (HA) coating, perASTM F1185.	Equivalent

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Osseus

use. The instruments used toinsert the cage are manufacturedfrom medical grade stainless steeland must be sterilized prior touse. The screws, anchors,blocking plates, and instrumentsare supplied in a re-usable tray forsteam sterilization.
Interbody Heights	9-19 mm in 2 mm increments	11-21 mm in 2 mm increments	Equivalent
Footprints	23x29 mm, 26x35 mm, 29x39 mm	24x30 mm, 26x34 mm, 29x39 mm	Equivalent
Lordotic Angles	8°, 16°, 20°, 24°	8°, 15°, 20°, 25°, 30°	Equivalent
Standalone FixationTechnology	Screws or Anchors	Screws or Anchors	Equivalent
Screw Diameters	Ø4.8 mm and Ø5.25 mm	Ø5.5 mm	Equivalent
Screw Lengths	15-52.5 mm in 2.5 mmincrements	20-60 mm in 5 mm increments	Equivalent
Screw Types	Fixed, Variable, Self-tapping,Self-drilling	Fixed, Variable, Self-tapping,Self-drilling	Equivalent
Anchor Diameter	Ø4.8 mm	Ø5.5 mm	Equivalent
Anchor Lengths	22.5 mm, 25 mm, 27.5 mm	20 mm, 25 mm, 27 mm, 30 mm,35 mm, 40 mm	Equivalent
Materials	Ti-6Al-4V ELI per ASTM F3001and ASTM F136	Ti-6Al-4V ELI per ASTM F3001,Titanium alloy per ASTM F135and F1295, and/or cobalt chromealloy per ASTM F1537	Equivalent

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Image /page/12/Picture/0 description: The image shows the word "OSSEUS" in a stylized font. The first letter, "O", is a square with a dot in the center. The rest of the letters are in a sans-serif font, with the "E" represented by three horizontal lines. The color of the text transitions from purple to blue.

Non-clinical Testing:

Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression per ASTM F2077, static and dynamic compression shear per ASTM F2077, subsidence per ASTM F2267, expulsion testing, cantilever anchor bending, and anchor impaction testing. Substantial equivalence is also supported by performing cadaveric implantation and cadaveric Range of Motion (ROM) studies.

Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.