← Product Code [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS) · K960988

# LACTOSORB TRAUMA PLATING SYSTEM (K960988)

_Poly-Medics,Inc. · HRS · Apr 10, 1996 · Orthopedic · SN_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K960988

## Device Facts

- **Applicant:** Poly-Medics,Inc.
- **Product Code:** [HRS](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS.md)
- **Decision Date:** Apr 10, 1996
- **Decision:** SN
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3030
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The LactoSorb® Trauma Plating System is indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton. 1. Comminuted fractures of the naso-ethmoidal and infraorbital areas. 2. Comminuted fractures of the frontal sinus wall. 3. Trauma of the midface or craniofacial skeleton. 4. Reconstructive procedures of the midface or craniofacial skeleton. This system is not designed for use in the mandible and/or full load bearing procedures.

## Device Story

LactoSorb® Trauma Plating System consists of bioresorbable plates and screws for fixation in midface/craniofacial trauma and reconstruction. Implants fabricated from synthetic PLA/PGA copolymer; degrades in vivo via hydrolysis into lactic and glycolic acids; metabolized by body. System provides fixation equivalent to metal micro-fixation systems; eliminates need for secondary removal surgery due to complete resorption within 12 months. Used by surgeons in clinical settings for bone stabilization.

## Clinical Evidence

Effectiveness determined by mechanical testing and an FDA-approved clinical study. Results indicate the system provides adequate fixation in the craniomaxillofacial region, comparable to metal micro-fixation systems, with complete resorption observed by 12 months in vivo.

## Technological Characteristics

Bioresorbable synthetic polyester copolymer (PLA/PGA). Biocompatible. Designed for midface/craniofacial fixation. Resorption profile: complete degradation by 12 months in vivo.

## Regulatory Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

## Reference Devices

- Poly Surgiclip®

## Submission Summary (Full Text)

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K960988
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# SUMMARY OF SAFETY AND EFFECTIVENESS

The LactoSorb® Trauma Plating System is indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton.

1. Comminuted fractures of the naso-ethmoidal and infraorbital areas.
2. Comminuted fractures of the frontal sinus wall.
3. Trauma of the midface or craniofacial skeleton.
4. Reconstructive procedures of the midface or craniofacial skeleton.

This system is not designed for use in the mandible and/or full load bearing procedures.

The LactoSorb® implants are made of bioresorbable and biocompatible polymer that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is a synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic (PLA/PGA) acid copolymer degrades and resorbs IN VIVO by hydrolysis to lactic and glycolic acids which are then metabolized by the body. The safety of PLA/PGA material has been well documented since the early 1970's when the FDA first approved the use of resorbable PLA/PGA sutures. The exact same LactoSorb® material has been implanted in humans for over 10 years in Poly Surgiclip® device manufactured by United States Surgical Corporation. The LactoSorb® material has been found to be biocompatible in both soft and hard bone tissue.

The effectiveness of this resorbable system was determined by mechanical testing and an FDA approved clinical study. The LactoSorb® system was found to provide adequate fixation in the craniomaxillofacial region. This system is as effective as similar metal micro fixation systems on the market. The devices completely resorb by 12 months IN VIVO eliminating the need for long-term removal.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K960988](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HRS/K960988)

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