← Product Code [HWQ](/submissions/OR/subpart-e%E2%80%94surgical-devices/HWQ) · K970360

# MITEK SUTURE RETROGRADER (K970360)

_Mitek Products · HWQ · Mar 10, 1997 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWQ/K970360

## Device Facts

- **Applicant:** Mitek Products
- **Product Code:** [HWQ](/submissions/OR/subpart-e%E2%80%94surgical-devices/HWQ.md)
- **Decision Date:** Mar 10, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.4540
- **Device Class:** Class 1
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

Retrograde suture through soft tissue

## Device Story

Hand-held surgical instrument; used to retrograde suture through soft tissue. Operates in open or arthroscopic procedures. Physician-operated. Device consists of gamma-stable Lexan handle and stainless steel components. Functionally equivalent to existing suture passers; facilitates suture placement in surgical sites.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Materials: Gamma-stable Lexan (handle), stainless steel (components). Form factor: Hand-held surgical instrument. Sterilization: Not specified.

## Regulatory Identification

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

## Predicate Devices

- Acufex suture retrograder
- Innovasive suture passer

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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K970360

# SUMMARY OF SAFETY AND EFFECTIVENESS
## MITEK SUTURE RETROGRADER

MAR 10 1997

## SUBMITTER

|  NAME | Mitek Products  |
| --- | --- |
|  ADDRESS | 60 Glacier Drive, Westwood, MA 02090  |
|  TEL # | 617-461-9700  |
|  CONTACT | Edward F. Kent Vice President
Regulatory Affairs  |
|  DATE | January 10, 1997  |

## NAME OF DEVICE

|  CLASSIFICATION NAME | SUTURE PASSER, 87HWQ  |
| --- | --- |
|  COMMON NAME | Instrument to retrograde suture through tissue  |
|  PROPRIETARY NAME | MITEK Suture Retrograder  |

## PREDICATE DEVICE

- Acufex suture retrograder, and
- Innovasive suture passer

## DESCRIPTION OF DEVICE

### FUNCTION

The suture retrograder is used to retrograde (pass) suture through soft tissue.

### MATERIALS USED

The handle is molded from gamma stable Lexan with the remaining materials being made from stainless steel.

### INTENDED USE

Retrograde suture through soft tissue

### COMPARISON TO PREDICATE DEVICE(S)

Same function, hand held suture retrograde instrument to pass or retrograde suture through tissue in either open or arthroscopic procedures.

### DESCRIPTION OF NON CLINICAL TESTS

Bench tests were done to demonstrate performance equivalence to predicate devices on the market.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWQ/K970360](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWQ/K970360)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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