Pisces™-SA STANDALONE ALIF Interbody System

K223413 · Osseus Fusion Systems · OVD · Feb 10, 2023 · Orthopedic

Device Facts

• Record ID: K223413
• Device Name: Pisces™-SA STANDALONE ALIF Interbody System
• Applicant: Osseus Fusion Systems
• Product Code: OVD · Orthopedic
• Decision Date: Feb 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PISCES™-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 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. PISCES™-SA Used with Screws and/or Anchors: - When used with three (3) anchors, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 level without the need for supplemental fixation. - 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 without the need for supplemental fixation. - Hyperlordotic interbody devices (>20° lordosis) used with screws and/or anchors must always be used with supplemental fixation and may be used at 1 or 2 contiguous levels. PISCES™ 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.

Device Story

Lumbar interbody fusion device; provides structural support to disc space; filled with autograft/allograft bone to facilitate fusion. Used in ALIF procedures; surgeon-operated. Integrated fixation (screws/anchors) allows standalone use at specific levels/lordotic angles; otherwise requires supplemental posterior/anterior fixation. Titanium alloy construction; provides stability to spinal segment; promotes fusion; reduces discogenic pain.

Clinical Evidence

Bench testing only. Mechanical testing included static/dynamic compression (ASTM F2077), compression shear (ASTM F2077), subsidence (ASTM F2267), expulsion, cantilever anchor bending, and anchor impaction. Additional evidence provided via cadaveric implantation, range of motion (ROM), fatigue studies, and void analysis.

Technological Characteristics

Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 (spacers) and ASTM F136 (screws/anchors). Interbody fusion device; standalone or supplemental fixation. Dimensions: 9-19mm height, 23x29mm to 29x39mm footprints, 8°-24° lordosis. Sterilization: Gamma radiation (spacers); steam sterilization (reusable instruments/trays).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) or one or more levels (T1-S1) depending on fixation method. Includes patients with Grade 1 spondylolisthesis/retrolisthesis, disc herniation, deformity, spinal stenosis, or failed previous fusion. Requires 6 months of failed non-operative treatment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PISCES™-SA STANDALONE ALIF Interbody System (K213935)

Submission Summary (Full Text)

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February 10, 2023

Osseus Fusion Systems % Ms. Jennifer Palinchik President JALEX Medical LLC 27865 Clemens Rd Suite 3 Westlake, Ohio 44145

Re: K223413

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 Dated: January 18, 2023 Received: January 30, 2023

Dear Ms. Palinchik:

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 ([e-mail]) or phone [phone] 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) K223413

Device Name PISCESTM-SA Standalone ALIF Interbody System

### Indications for Use (Describe) 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 at the involved level(s). These patients should be sketally 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 and/or Anchors:

When used with three (3) anchors, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 level without the need for supplemental fixation.

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 without the need for supplemental fixation.

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

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 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/1 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 rounded edges. The color of the letters transitions from purple to blue. There is a trademark symbol next to the last letter.

## 510(k) Summary

| Submitted By: | Osseus Fusion Systems<br>1931 Greenville Ave.<br>Suite 200<br>Dallas, TX 75206 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Date: | 02/08/2023 |
| Contact Person: | Jennifer Palinchik, JALEX Medical, President (consultant) |
| Contact Telephone: | [phone] |
| Contact Fax: | [phone] |
| Device Trade Name: | PISCES™-SA STANDALONE ALIF Interbody System |
| Device Classification Name: | Intervertebral Body Fusion Device with Integrated Fixation, Lumbar |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | OVD, MAX, PHM |
| Predicate Device: | K213935- PISCES™-SA STANDALONE ALIF Interbody System<br>The predicate device has not been subject to any design related recalls. |

### 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 and/or anchors, these devices are standalone interbody fusion devices. The integrated fixation anchors may not provide adequate stability for all situations. The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., anterior plate, posterior pedicle screws) may be needed. When used without screws and/or anchors, 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-6AI-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, 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.

## Intended Use:

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

The PISCES™S A (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-Sl). 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. 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 and/or Anchors:

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- When used with three (3) anchors, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 level without the need for supplemental fixation. -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 without the need for supplemental fixation.

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

### PISCESTM ALIF Spacers (Without Integrated Fixation) .

PISCES™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (TI-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (LI-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.

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## തടടലടച

## Summary of Technological Characteristics:

| | Table 1: Technological Characteristics Comparison | |
|--|---------------------------------------------------|--|
|--|---------------------------------------------------|--|

| Feature | Subject Device:<br>PISCES™-SA<br>Standalone ALIF<br>Interbody System | Primary Predicate:<br>K213935 -PISCES™-<br>SA Standalone ALIF<br>Interbody System | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Regulation | 888.3080 | 888.3080 | Equivalent |
| Product Code | OVD, MAX, PHM | OVD, MAX, PHM | Equivalent |
| Indications for Use | PISCES™-SA ALIF<br>Spacers (Standalone Use,<br>With Integrated Fixation)<br>The PISCES™-SA<br>(Standalone) ALIF<br>Interbody System are<br>lumbar interbody fusion<br>devices intended for use<br>in patients with<br>degenerative disc disease<br>(DDD) at one or two<br>contiguous levels of the<br>lumbosacral spine (L2-<br>S1). DDD is defined as<br>discogenic back pain with<br>degeneration of the disc<br>confirmed by history and<br>radiographic studies. In<br>addition, these patients<br>may have up to Grade 1<br>spondylolisthesis or<br>retrolisthesis at the<br>involved level(s). These<br>patients should be<br>skeletally mature and<br>have had at least six (6)<br>months of non-operative<br>treatment. PISCES™-SA<br>(Standalone) ALIF<br>Spacers are to be filled<br>with autograft bone<br>and/or allogenic bone<br>graft composed of<br>cancellous and/or<br>corticocancellous bone. | PISCES™-SA<br>Standalone ALIF<br>Interbody System is a<br>family of integrated<br>interbody fusion devices<br>indicated for one or<br>more contiguous levels<br>of the thoracic spine<br>(T1-T12, thoracolumbar<br>junction (T12-L1), or<br>lumbosacral spine (L1-<br>S1), as an adjunct to<br>fusion in patients with<br>the following<br>indications: degenerative<br>disc disease (DDD), disc<br>herniation (with<br>myelopathy and/or<br>radiculopathy), up to<br>Grade 1<br>spondylolisthesis or<br>retrolisthesis at involved<br>level(s), deformity<br>(degenerative scoliosis<br>or kyphosis), spinal<br>stenosis, and failed<br>previous fusion<br>(pseudarthrosis). DDD is<br>defined as a discogenic<br>back pain with<br>degeneration of the disc<br>confirmed by history<br>and radiographic studies.<br>These patients should be<br>skeletally mature and<br>have had at least (6)<br>months of non-operative<br>treatment.<br>PISCES™-SA<br>Standalone ALIF | Equivalent |
| | PISCES™-SA Used with<br>Screws and/or Anchors:<br>-When used with three (3)<br>anchors, interbody devices<br>with a lordotic angle ≤20° | | |

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## .

| can be used as<br>standalone interbody<br>fusion devices at 1 level<br>without the need for<br>supplemental fixation.<br>-When used with three (3)<br>screws, interbody devices<br>with a lordotic angle ≤20°<br>can be used as standalone<br>interbody fusion devices<br>at 1 or 2 contiguous levels<br>without the need for<br>supplemental fixation.<br>-Hyperlordotic interbody<br>devices (>20° lordosis)<br>used with screws and/or<br>anchors must always be<br>used with supplemental<br>fixation and may be used<br>at 1 or 2 contiguous<br>levels.<br>PISCES™ ALIF Spacers<br>(Without Integrated<br>Fixation)<br>PISCES™ ALIF Spacers<br>are lumbar interbody<br>fusion devices indicated<br>at one or more levels of<br>the thoracic spine (Tl-<br>T12), thoracolumbar<br>junction (T12-Ll), or<br>lumbosacral spine (Ll-Sl)<br>as an adjunct to fusion in<br>patients with the<br>following indications:<br>degenerative disc disease<br>(DDD), disc herniation<br>(with myelopathy and/or<br>radiculopathy),<br>spondylolisthesis,<br>deformity (degenerative<br>scoliosis or kyphosis),<br>spinal stenosis, and failed<br>previous fusion<br>(pseudarthrosis). DDD is<br>defined as discogenic<br>back pain with<br>degeneration of the disc<br>as confirmed by history<br>and radiographic studies. | Interbody System is<br>intended to be used with<br>or without three screws<br>or anchors which<br>accompany the<br>interbodies. When used<br>with screws, these<br>devices are standalone<br>interbody fusion devices<br>for one or two<br>contiguous levels of the<br>lumbosacral spine (L1-<br>S1). When used with<br>anchors, these devices<br>are stand-alone<br>interbody fusion devices<br>for one level of the<br>lumbosacral spine (L1-<br>S1). When used without<br>screws or anchors, these<br>devices are intended for<br>use with supplemental<br>fixation (e.g. facet<br>screws or posterior<br>fixation) for one or more<br>contiguous levels of the<br>thoracic spine (T1-T12,<br>thoracolumbar junction<br>(T12-L1), or<br>lumbosacral spine (L1-<br>S1). When used without<br>screws or anchors, these<br>devices with ≥ 20°<br>lordosis must be used<br>with at least anterior<br>supplemental fixation.<br>PISCES™-SA<br>Standalone ALIF<br>Interbody System is<br>designed for use with<br>autograft and/or<br>allogenic bone graft<br>composed of cancellous<br>and/or corticocancellous<br>bone graft to facilitate<br>fusion. |
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# തടടലടന

| These patients should be<br>skeletally mature and<br>have had at least six (6)<br>months of non-operative<br>treatment. PISCESTM<br>ALIF Spacers are to be<br>filled with autograft bone<br>and/or allogenic bone<br>graft composed of<br>cancellous and/or<br>corticocancellous bone.<br>These devices are<br>intended to be used with<br>supplemental fixation<br>systems that have been<br>cleared for use in the<br>thoracolumbosacral spine<br>(e.g., posterior pedicle<br>screw and rod systems,<br>anterior plate systems,<br>and anterior screw and<br>rod systems).<br>Hyperlordotic interbody<br>devices (≥20 lordosis)<br>must be used with at least<br>anterior supplemental<br>fixation. | | | |
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