ELID (Endoscopic Less Invasive Decompression) System

K243774 · Lesspine Innovations · HRX · Aug 27, 2025 · Orthopedic

Device Facts

• Record ID: K243774
• Device Name: ELID (Endoscopic Less Invasive Decompression) System
• Applicant: Lesspine Innovations
• Product Code: HRX · Orthopedic
• Decision Date: Aug 27, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ELID (Endoscopic Less Invasive Decompression) system intended to provide lumbar decompression of the spine to treat various spinal condition(s) using minimally invasive techniques and instrumentation.

Device Story

The ELID System is a set of manual surgical instruments used by surgeons to perform minimally invasive lumbar decompression. The system includes a bone needle, guidewire, flat blade dilator, dilator tubes, and rongeurs. The surgeon uses the bone needle and guidewire to navigate to the surgical site, followed by the flat blade dilator and dilator tubes to create the necessary access path. Finally, the rongeurs are used to remove bone and tissue to achieve decompression. The device is used in a clinical or surgical setting. The output is the physical removal of bone/tissue, which allows the surgeon to decompress the spine, potentially relieving symptoms associated with spinal conditions.

Clinical Evidence

Bench testing only. Testing included cleaning validation, sterilization validation, biocompatibility, usability testing, and particulate analysis per ASTM F1877. Results demonstrate that the system's strength is sufficient for its intended use and equivalent to predicate devices.

Technological Characteristics

Manual surgical instruments including bone needle, flat blade dilator, dilator tubes, and rongeurs. Materials: Aluminum (ASTM B211), Nitinol (ASTM F2063), and stainless steel (ASTM A564). Non-sterile, reusable. No energy source or software.

Indications for Use

Indicated for patients requiring lumbar decompression of the spine to treat various spinal conditions using minimally invasive techniques.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Vertos mild Device Kit (K233800)
• METRx™ System (K993012/K002931)

Reference Devices

• KLS Martin Neuro Rongeurs (K210741)
• Vitalitec Kerrison Rongeurs (K152734)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

August 27, 2025

LESpine Innovations
% Hannah Taggart
Regulatory Associate
Empirical Technologies
4628 Northpark Drive
Colorado Springs, Colorado 80918

Re: K243774
Trade/Device Name: ELID (Endoscopic Less Invasive Decompression) System
Regulation Number: 21 CFR 888.1100
Regulation Name: Arthroscope
Regulatory Class: Class II
Product Code: HRX
Dated: August 1, 2025
Received: August 1, 2025

Dear Hannah Taggart:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K243774 - Hannah Taggart
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K243774 - Hannah Taggart
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assistance/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,

JESSE
MUIR -S

Digitally signed by
JESSE MUIR -S
Date: 2025.08.27
14:42:07 -04'00'

Jesse Muir, Ph.D.
Assistant Director
DHT6C: Division of Restorative,
Repair, and Trauma 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: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K243774

Device Name
ELID (Endoscopic Less Invasive Decompression) System

Indications for Use (Describe)
The ELID (Endoscopic Less Invasive Decompression) system intended to provide lumbar decompression of the spine to treat various spinal condition(s) using minimally invasive techniques and instrumentation.

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)

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K243774 510(K) SUMMARY

| Submitter’s Name: | LESspine Innovations |
| --- | --- |
| Submitter’s Address: | 200 Summit Drive, Suite 505
Burlington MA 01803 |
| Submitter’s Telephone: | 617-820-2900 |
| Contact Person: | Hannah Taggart, MS
Empirical Technologies
719- 457-1152
[e-mail] |
| Date Summary was Prepared: | August 1, 2025 |
| Trade or Proprietary Name: | ELID (Endoscopic Less Invasive Decompression) System |
| Device Classification Name: | Arthroscopic Accessories |
| Classification & Regulation #: | Class II per 21 CFR §888.1100 |
| Product Code: | HRX |
| Classification Panel: | Orthopedic |

## DEVICE DESCRIPTION AND TECHNOLOGY

The ELID (Endoscopic Less Invasive Decompression) System consists of instrumentation intended to aid the user in completing steps necessary to perform lumbar decompression. Instruments include a bone needle, flat blade dilator, dilator tubes, and rongeurs. Instruments in the ELID (Endoscopic Less Invasive Decompression) System are supplied non-sterile, reusable, and manufactured from aluminum per ASTM B211, Nitinol per ASTM 2063, or stainless steel per ASTM A564.

## INDICATIONS FOR USE

The ELID (Endoscopic Less Invasive Decompression) System is intended to provide lumbar decompression of the spine to treat various spinal condition(s) using minimally invasive techniques and instrumentation.

## TECHNOLOGICAL CHARACTERISTICS

The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

- Indications for Use
- Materials of manufacture
- Device Components

Predicate Devices

| 510k Number | Trade or Proprietary | Manufacturer | Product Code | Predicate Type |
| --- | --- | --- | --- | --- |
| K233800 | Vertos mild Device Kit | Vertos Medical | HRX, HAE | Primary |
| K993012/K002931 | METRx™ System | Medtronic Sofamor Danek, Inc. | HRX | Additional |
| K210741 | KLS Martin Neuro Rongeurs | KLS-Martin L.P. | HAE | Reference |
| K152734 | Vitalitec Kerrison Rongeurs | Vitalitec Medizintechnik GmbH | HAE | Reference |

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| | | ELID System
(Subject Device) | Vertos Medical mild Device Kit
(K233800) | Medtronic Sofamor Danek, Inc., METRx™ System
(K993021/K002931) | KLS Martin Neuro Rongeurs
(K210741) | Vitalitec Kerrison Rongeurs
(K152734) |
| --- | --- | --- | --- | --- | --- | --- |
| Indications for Use | | The ELID (Endoscopic Less Invasive Decompression) System intended to provide lumbar decompression of the spine to treat various spinal condition(s) using minimally invasive techniques and instrumentation. | The Vertos Medical mild Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions. | The METRx™ Microscope is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the METRx™ Microscope and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. | The KLS Martin Neuro Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older. | Vitalitec Kerrison Rongeurs are manually operated reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column. |
| Classification | | 888.1100 | 888.1100 | 888.1100 | 882.4840 | 882.4840 |
| Product Code | | HRX, HAE | HRX, HAE | HRX | HAE | HAE |
| Sterility | | Non-sterile, reusable | Sterile, single-use | Non-sterile | Non-sterile, reusable | Non-sterile, reusable |
| Device Components | Navigation to Site | Bone Needle
Material: Stainless Steel
Guidewire
Material: Nitinol per ASTM F2063
Size: Ø1.5mm x 500 mm | mild Initiator
Material: Acrylonitrile butadiene styrene, stainless steel, polycarbonate, thermoplastic elastomer | Guidewire
Material: Unknown
Sizes: Ø1.57 mm x 300 mm | Not Applicable | Not Applicable |
| | Dilation of Site | Flat Blade Dilator
Material: 17-4 PH SS per ASTM A564
Dilator Tubes
Material: 7075-T6 Al per ASTM B211
Sizes: Ø6.0mm, Ø8.0mm, Ø12.9mm, Ø16.3mm | mild Access Auger
Material: Stainless Steel | Dilators
Material: Unknown
Sizes: Ø5.3 mm – Ø24.8 mm | Not Applicable | Not Applicable |
| | Tissue/Bone Removal | Kerrison Rongeur
Material: Stainless Steel
Sizes: 3mm, 5mm, 4mm, 6mm | mild Bone Rongeur
Material: Stainless Steel
mild Tissue Sculptor
Material: Acrylonitrile butadiene styrene, stainless steel, nylon, zinc-plated wire | Kerrison Rongeur
Material: Unknown
Sizes: 1mm, 2mm, 3mm, 4mm, 5mm | Kerrison Rongeur
Material: Stainless Steel, TiAlN coating, gold plating
Sizes: 1mm to 6mm | Kerrison Rongeur
Material: Stainless Steel, TiAlN coating
Sizes: 1mm to 6mm |

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The subject device is different from the predicate device in that the subject system includes a flat blade dilator and guidewire which the predicate devices do not use during the decompression procedure. Both the subject flat blade dilator and guidewire have been cleared and remain unchanged since their previous submission.

## PERFORMANCE DATA

The ELID (Endoscopic Less Invasive Decompression) System has been tested in the following test modes:

- Cleaning Validation
- Sterilization Validation
- Biocompatibility
- Usability Testing
- Particulate Analysis per ASTM F1877

The results of this non-clinical testing show that the strength of the ELID (Endoscopic Less Invasive Decompression) System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

## CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the ELID (Endoscopic Less Invasive Decompression) System is substantially equivalent to the predicate device.

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