(58 days)
K 210035, K 152237
Not Found
No
The document describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for sacroiliac joint fusion to treat conditions like sacroiliac joint disruptions and degenerative sacroiliitis, which is a therapeutic purpose.
No
This device is a surgical implant designed for sacroiliac joint fusion, not for diagnosing medical conditions. Its purpose is to physically stabilize the joint.
No
The device description explicitly states it consists of bone screws made from titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The ZESPIN SI Joint Fusion System is a system of bone screws designed to be implanted inside the patient's body to fuse the sacroiliac joint.
- Intended Use: The intended use is for sacroiliac joint fusion, which is a surgical procedure performed on the patient.
The description clearly indicates a surgically implanted device, not a device used for testing biological samples in a lab.
N/A
Intended Use / Indications for Use
The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The ZESPIN SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136. The subject submission introduces additional designs and sizes of the arch screw and locking screw.
- Arch Screw will be implanted in patient's bone then autograft will be inserted.
- Locking Screw can be used with washer or can be used on its own
- Self-tapping flute centers screw for easy insertion
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A risk assessment, including FE analysis, was conducted to confirm that the additional components do not introduce new issues of safety or effectiveness. The risk assessment confirmed that none of the additional components is the worst case of the ZESPIN SI Joint Fusion System and the additional components added through this submission do not require additional mechanical testing.
Therefore, we substitute mechanical test data of ZESPIN SI Joint Fusion System for additional components with the predicate device data (K210035).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 210035, K 152237
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
January 20, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Aegis Spine, Inc. Kihyang Kim RA 9781 S. Meridian Blvd. Ste 300 Englewood, Colorado 80112
Re: K223521
Trade/Device Name: ZESPIN SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: November 20, 2022 Received: November 23, 2022
Dear Kihyang Kim:
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 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
1
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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E. 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
2
Indications for Use
510(k) Number (if known) K223521
Device Name
ZESPIN SI Joint Fusion System
Indications for Use (Describe)
The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroiliitis.
| Type of Use (Select one or both, as applicable) | |||
|---|---|---|---|
| X Prescription Use (Part 21 CER 801 Subpart D) | Over The Counter Use (21 C.FR 801 Submart C) |
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3
Image /page/3/Picture/0 description: The image shows the text "K223521 Page 1 of 2" at the top left corner. To the right of this text is a logo featuring a blue circle with a white letter "A" inside. Below the circle, the word "AEGIS" is written in a stylized font, also in blue. The logo appears to be a company logo.
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
1. MANUFACTURER
| Submitter's Name: | Aegis Spine, INC. |
|---|---|
| Submitter's Address: | 9781 S. Meridian Blvd, Ste 300 |
| Englewood, CO 80112 | |
| Submitter's Telephone: | +1.303.741.4123 |
| Contact Person: | Kihyang Kim |
| +1.303.741.4123 | |
| khkim@aegisspine.com/khkim3747@gmail.com |
2. DEVICE IDENTIFICATION
| Device Trade Name | ZESPIN SI Joint Fusion System |
|---|---|
| Common/Usual Name | Sacroiliac joint fixation, Bone Screw |
| Regulation Class /Number | Class II / 21 CFR 888.3040 |
| Regulation Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | OUR |
| Classification Panel | Spinal Devices (DHT6B) |
3. PREDICATE OR LEGALLY MARKETED DEVICES WHICH ARE SUBSTANTIALLY EQUIVALENT.
The subject devices are similar to the predicate devices in all characteristics.
| Subject Device Name | 510K NO. | Trade or Proprietary or Model Name | Predicate Type |
|---|---|---|---|
| ZESPIN SI Joint | K 210035 | ZESPIN SI Joint Fusion System | Primary |
| Fusion System | K 152237 | Entasis™ Dual-Lead Sacroiliac Implant | Additional |
The design feature, indications for use and manufacturing process for the subject devices are substantially equivalent to the predicate devices.
4. MATERIALS
| ZESPIN SI Joint Fusion System | Ti-6Al-4V ELI titanium alloy (ASTM F136) |
|---|---|
| And the additional components material is the same material used in the predicate devices (K210035) |
And the additional components material is the same material used in the predicate devices (K 210035).
ട്. DESCRIPTION OF THE DEVICE
The ZESPIN SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136. The subject submission introduces additional designs and sizes of the arch screw and locking screw.
- Arch Screw will be implanted in patient's bone then autograft will be inserted. ●
- . Locking Screw can be used with washer or can be used on its own
- . Self-tapping flute centers screw for easy insertion
6. INDICATION FOR USE
The ZESPIN SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
4
7. PERFORMANCE TESTING
ZESPIN SI Joint Fusion System
A risk assessment, including FE analysis, was conducted to confirm that the additional components do not introduce new issues of safety or effectiveness. The risk assessment confirmed that none of the additional components is the worst case of the ZESPIN SI Joint Fusion System and the additional components added through this submission do not require additional mechanical testing.
Therefore, we substitute mechanical test data of ZESPIN SI Joint Fusion System for additional components with the predicate device data (K210035).
8. SUMMARY OF TECHNOLOGY CHARACTERISTICS
Subject devices are similar to the predicate devices in all (Material, Indication for use, Design, Manufacturing process, Surgical approach) characteristics
SUBSTANTIAL EQUIVALENCE 9.
Subject devices are substantially equivalent to the predicate devices in indications for use, design, function and materials used.
10. CONCLUSION
The overall technology characteristics lead to the conclusion that the ZESPIN SI Joint Fusion System is substantially equivalent to the predicate devices(K210035).