GAP ENDO-EXO MEDULLARY SYSTEM
Device Facts
| Record ID | K111232 |
|---|---|
| Device Name | GAP ENDO-EXO MEDULLARY SYSTEM |
| Applicant | Pega Medical, Inc. |
| Product Code | HSB · Orthopedic |
| Decision Date | Jan 26, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3020 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surqically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) age 2 to 21. It can be used to correct the following conditions: - Diaphyseal facture of the femur, tibia and humerus . - Fractures of the femoral neck . - . Subtrochanteric, intertrochanteric and combination fractures - . Correction of deformities (OI, Coxa vara, Coxa valga) - . Nonunions and malunions
Device Story
The GAP Endo-Exo Medullary System is an orthopedic fixation device consisting of a cannulated intramedullary nail linked to plates via mechanical screws. It functions as a combined endo-medullary/exo-medullary osteosynthesis system. Used by surgeons in clinical settings to stabilize long bone fractures or correct deformities in pediatric patients. The device provides mechanical support to bone segments to facilitate healing and alignment. It is a purely mechanical implant system.
Clinical Evidence
No clinical testing was provided. Safety and effectiveness were established through bench testing, specifically static 4-point bending, torsion, and 4-point bending fatigue tests conducted in accordance with ASTM 1264.
Technological Characteristics
Intramedullary cannulated nail with plates and 3-4mm cortical screws. Mechanical fixation device. Testing performed per ASTM 1264 standard specifications and test methods for intramedullary fixation devices.
Indications for Use
Indicated for pediatric patients (age 2-21) requiring alignment, stabilization, and fixation of long bones (femur, tibia, humerus) following osteotomy, trauma, or disease-related fractures, deformities (OI, Coxa vara, Coxa valga), nonunions, or malunions.
Regulatory Classification
Identification
An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
Predicate Devices
- Fassier-Duval Telescopic IM System (K041393/K020885)
- Synthes Adolescent Lateral Entry Femoral Nail System (K070843)
- Titanium Pediatric Femoral Nail (K993956)
Related Devices
- K160545 — GAP ENDO-EXO MEDULLARY SYSTEM · Pega Medical, Inc. · Nov 23, 2016
- K143245 — GPC Intramedullary Nailing Systems · Gpc Medical Limited · Sep 30, 2015
- K082375 — ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM · OrthoPediatrics Corp. · Oct 17, 2008
- K021324 — FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) · Disco-O-Tech Medical Technologies, Ltd. · May 23, 2002
- K173051 — Orthofix MJ-FLEX THE NEW METAIZEAU NAIL · Orthofix Srl · Nov 16, 2017
Submission Summary (Full Text)
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JAN 2 6 2012
K111232
Montreal, January 16th, 2012
## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant: Pega Medical Inc. 1111 Autoroute Chomedey Laval, Quebec H7W 5J8 Canada
Contact Person: Ariel R. Duiovne
Proprietary Name: GAP Endo-Exo Medullary System
Common Name: Intramedullary Nail
Device Classification: Class II
Classification Name: Rod, Fixation, Intramedullary And Accessories 21 CFR 888-3020
Device Product Code: HSB
#### Establishment Reqistration Number: 9048931
Intended Use: The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surqically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) age 2 to 21. It can be used to correct the following conditions:
- Diaphyseal facture of the femur, tibia and humerus .
- Fractures of the femoral neck .
- . Subtrochanteric, intertrochanteric and combination fractures
- . Correction of deformities (OI, Coxa vara, Coxa valga)
- . Nonunions and malunions
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K111232
Description: The GAP Endo-Exo Medullary System consists of an intramedullary cannulated nail linked to various types of plates via and/or mechanical screws creating a a combined laq Endoamedullary/ Exomedullary osteosythesis device. 3 and 4mm cortical screws are used to secure the nail to the bone.
#### Basis for substantial equivalent:
The GAP Endo-Exo Medullary System is claimed to be substantially equivalent in design and function to the following predicate devices:
- Fassier-Duval Telescopic IM System (Stainless steel or Ti 1. pediatric nail), Pega Medical Inc. (K041393/K020885)
- 2. Synthes Adolescent Lateral Entry Femoral Nail System (Ti alloy nail and screws), Synthes USA. (K070843)
- 3. Titanium Pediatric Femoral Nail (Ti alloy nail and screws) Biomet Inc. (K993956)
The intended uses of these devices are the same as the GAP Endo-Exo Medullary System
Summary of Technologies: The technological characteristics of the GAP Endo-Exo Medullary System are the same or similar to the ones of the predicate devices.
Biomechanical Testing: A static 4 point bending test, torsion test and 4 point bending fatique test based on the ASTM standard 1264 "Standard Specifications and Test Method L for Intramedullary Fixation Devices" were performed to demonstrate safety. The results indicated that the GAP Endo-Exo Medullary System is functionally safe for its intended use.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence. A clinical data report based on equivalent products can be found in Appendix H.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pega Medical Inc % Mr. Ariel R. Dujovne 1111 Autoroute Chomedey Laval, Quebec H7W 5J8 Canada
JAN 2 6 2012
Re: K111232
Trade/Device Name: GAP Endo-Exo Medullary System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: January 16. 2012 Received: January 18, 2012
Dear Mr. Dujovne:
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. 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 801); medical device reporting (reporting of medical
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Page 2 - Mr. Ariel R. Dujovne
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N Melkerson Director Division of Surgical, Orthopedic & Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use Statement
510(k) Number (if known):
#### Device Name: GAP ENDO-EXO MEDULLARY SYSTEM
Indications for Use:
The GAP Endo-Exo Medullary System is indicated as a temporary implant to assure alignment, stabilization and fixation of: long bones that have been surgically prepared (osteotomy) for correction of deformities or fractures caused by trauma or disease. The GAP Endo-Exo Medullary System is used for pediatric patients (child and adolescent) age 2 to 21. It can be used to correct the following conditions:
- Diaphyseal facture of the femur, tibia and humerus .
- Fractures of the femoral neck .
- Subtrochanteric, intertrochanteric and combination fractures .
- Correction of deformities (OI, Coxa vara, Coxa valga) ●
- Nonunions and malunions .
Over-The-Counter Use _ Prescription Use no AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tan N. Phyp
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for (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K\1232
