DePuy CONDUIT LLIF Angled Inserters

K212823 · Enztec Limited · MAX · Nov 1, 2021 · Orthopedic

Device Facts

• Record ID: K212823
• Device Name: DePuy CONDUIT LLIF Angled Inserters
• Applicant: Enztec Limited
• Product Code: MAX · Orthopedic
• Decision Date: Nov 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy CONDUIT™ LLIF Angled Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages. EIT Cellular Titanium® LLIF Cage The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nano-scale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

DePuy CONDUIT LLIF Angled Inserters are reusable surgical instruments designed for lateral lumbar interbody fusion (LLIF) procedures. Instruments interface specifically with EIT Cellular Titanium LLIF Cages to facilitate cage insertion into the intervertebral space. Used by surgeons in clinical/OR settings; instruments provide mechanical guidance and placement control for the implant. Device does not perform automated analysis or provide clinical decision support; it serves as a manual tool for implant delivery. Benefit to patient is the accurate, controlled placement of spinal fusion hardware during degenerative disc disease treatment.

Clinical Evidence

Bench testing only. No clinical data provided. Performance confirmed via functionality, impact endurance, thread endurance, and formative usability testing.

Technological Characteristics

Constructed from Stainless Steel (ASTM F899) and Radel (USP Class VI). Manual surgical instrument; non-sterile; reusable. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, including those with up to Grade 1 spondylolisthesis or retrolisthesis, requiring intervertebral body fusion with autogenous or allogeneic bone graft and supplemental fixation, following at least six 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

• CONDUIT™ Instruments (K210728)
• EIT Cellular Titanium® Cages (K201605)

Submission Summary (Full Text)

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November 1, 2021

Enztec Limited Meredith May Director of Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K212823

Trade/Device Name: DePuy CONDUIT LLIF Angled Inserters Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 2, 2021 Received: September 3, 2021

Dear Meredith May:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 mediation-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.

for 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

| 510(k) Number ( <i>if known</i> ) | |
|-----------------------------------|--|
| K212823 | |
| Device Name | |

DePuy CONDUIT™ LLIF Angled Inserters

Indications for Use (Describe)

The DePuy CONDUIT™ LLIF Angled Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

EIT Cellular Titanium® LLIF Cage

The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nano-scale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

| Type of Use (Select one or both, as applicable) | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| <table><tr><td><span style="text-decoration: underline;"> <table><tr><td><div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td><td><div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div></td></tr></table> </span></td></tr></table> | <span style="text-decoration: underline;"> <table><tr><td><div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td><td><div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div></td></tr></table> </span> | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
| <span style="text-decoration: underline;"> <table><tr><td><div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td><td><div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div></td></tr></table> </span> | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |
| <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | | |

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# 5.510(K) SUMMARY

| Submitter's Name: | Enztec Limited |
|----------------------------|-------------------------------------------------------------------------------------------------|
| Submitter's Address: | 3/17 Print Place<br>Middleton, Christchurch 8024 |
| Submitter's Telephone: | [phone] |
| Contact Person: | Meredith Lee May MS, RAC<br>Empirical Testing Corp.<br>1-719-337-7579<br>[e-mail] |
| Date Summary was Prepared: | September 2, 2021 |
| Trade or Proprietary Name: | DePuy CONDUIT™ LLIF Angled Inserters |
| Common or Usual Name: | Implant insertion tool for intervertebral fusion device with<br>bone graft, lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Spinal Devices (DHT6B) |

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The CONDUIT™ Lateral Angled Inserters are designed for use during Lumbar Interbody Fusion surgery, specifically using a lateral approach. The instruments have been designed specifically to interface with the EIT Cellular Titanium® Cages (K201605). The reusable instruments are provided non-sterile and made from commonly used orthopedic materials with commonly used manufacturing processes. There are no changes to the implants or to other instruments provided with the implants.

### INDICATIONS FOR USE

The DePuy CONDUITTM LLIF Angled Inserters are intended to be used with the EIT Cellular Titanium® LLIF Cages.

EIT Cellular Titanium® LLIF Cage

The EIT Cellular Titanium® LLIF Cages with a microscopic roughened surface and micro and nano-scale features are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. EIT Spine LLIF is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

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# TECHNOLOGICAL CHARACTERISTICS

DePuy CONDUIT™ LLIF Angled Inserters are made from Stainless Steel per ASTM F899 and Radel in conformance with USP Class VI. The subject and predicate devices have nearly identical technological characteristics. Specifically, the following characteristics are identical between the subject and predicates:

- Indications for Use ●
- Materials of manufacture ●
- Sterility
- Compatibility

| | Table 5-1 Predicate Devices | |
|--|-----------------------------|--|
| | | |

| 510k<br>Number | Trade or Proprietary or<br>Model Name | Manufacturer | Product<br>Code | Predicate<br>Type |
|----------------|---------------------------------------|----------------------------------------------------------------------------|-----------------|-------------------|
| K210728 | CONDUIT™ Instruments | DePuy Synthes | ODP,<br>MAX | Primary |
| K201605 | EIT Cellular Titanium®<br>Cages | EIT Emerging Implant<br>Technologies GmbH<br>(with DePuy Synthes<br>Spine) | ODP,<br>MAX | Additional |

# PERFORMANCE DATA

Non-clinical testing was conducted to confirm device performance per intended use including functionality bench test, impact endurance test, thread endurance test, and formative usability test. The results of this non-clinical testing show that the performance of the DePuy CONDUIT™ LLIF Angled Inserters are sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

### CONCLUSION

The overall technology characteristics and performance data lead to the conclusion that the DePuy CONDUIT™ LLIF Angled Inserters are substantially equivalent to the predicate device.