(90 days)
The Guided Growth Plates are designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion; extension deformities of the knee (femur and/or tibia), valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
The Guided Growth System is designed for the gradual correction of pediatric deformities in both the upper and lower extremities. The device can be used for correction of congenital and acquired deformities provided that the physis (growth plates) are not fused. The plates feature a contoured waist and low profile for pediatric usage. There is a center hole in the plate for a temporary guide pin to be implanted to ensure accurate application of the plate. The plates are attached to the external surface of the bone over the growth plate by two or four screws. These screws are not locked to the plate, but rather are allowed to swivel and diverge in their position as bone growth occurs. The implant acts like a flexible hinge, permitting growth at the growth plate to gradually straighten the limb. Immediately after implantation, the patient is allowed mobility and weight bearing. The plates and screws are made from implant quality stainless steel conforming to ASTM F-138.
The provided text describes the acceptance criteria and a study for the "Guided Growth System Stainless Steel eight-Plate/quad-Plate". Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Properties: Demonstrate that the Stainless Steel Guided Growth System has the mechanical properties necessary to perform its intended use. | The results of the testing demonstrated the Stainless Steel Guided Growth System to meet or exceed all testing requirements. |
| Equivalence to Predicate Device: Perform as well as the predicate device regarding mechanical properties. | The results of the testing demonstrated the Stainless Steel Guided Growth System to perform as well as the predicate device. |
| Material Conformance: Made from implant quality stainless steel conforming to ASTM F-138. | The plates and screws are made from implant quality stainless steel conforming to ASTM F-138. (Also explicitly stated as "Implant quality stainless steel (316L)" in the features table). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes biomechanical testing rather than clinical or performance data from human subjects. Therefore, the concept of a "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) and sample size for human subjects is not applicable here. The testing was performed on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not by expert medical consensus in the typical sense of a clinical study.
4. Adjudication Method for the Test Set
Not applicable. This is typically relevant for clinical studies involving human interpretation or assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a bone plate for surgical use, not an AI-powered diagnostic tool. The study described is biomechanical testing.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This section is irrelevant as the device is a medical implant and not an algorithm.
7. The Type of Ground Truth Used
For the biomechanical testing, the ground truth was established by:
- Engineering Requirements/Standards: The device needed to meet or exceed "all testing requirements" and perform "as well as the predicate device." These requirements would be based on established engineering principles and standards for medical implants.
- Predicate Device Performance: The performance of the legally marketed predicate devices (Growth Guidance Plate - eight-Plate K031439/11-20-03 and Guided Growth System - quad-Plate K093442/06-10-10) served as a benchmark for comparison.
8. The Sample Size for the Training Set
Not applicable. This concept is for machine learning models, and this document describes mechanical testing of a physical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, this is for machine learning models.
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510(k) SUMMARY
. . .
Guided Growth System Stainless Steel eight-Plate/quad-Plate
JUN 2 1 2011
| Summary Date: | March 7, 2011 |
|---|---|
| Submitter Data: | Orthofix Inc.3451 Plano ParkwayLewisville, TX 75656214-937-2000214-937-2764 (fax) |
| Primary Contact: | Darla Chewdarlachew@orthofix.com |
| Device Trade Name: | Guided Growth System - stainless steel eight-Plate/quad-Plate |
| Common Name: | bone plate |
| Classification Name: | Single/multiple component metallic bone fixation appliances andaccessories. (21 CFR Parts 888.3030 |
| Product Code: | OBT - plate, bone, growth control, pediatric, epiphysiodesis |
| Legally MarketedPredicate Devices: | Growth Guidance Plate (eight-Plate) K031439/ 11-20-03Guided Growth System (quad-Plate) K093442/ 06-10-10 |
| Device Description: | The Guided Growth System is designed for the gradual correction ofpediatric deformities in both the upper and lower extremities. The devicecan be used for correction of congenital and acquired deformitiesprovided that the physis (growth plates) are not fused. The plates featurea contoured waist and low profile for pediatric usage. There is a centerhole in the plate for a temporary guide pin to be implanted to ensureaccurate application of the plate. The plates are attached to the externalsurface of the bone over the growth plate by two or four screws. Thesescrews are not locked to the plate, but rather are allowed to swivel anddiverge in their position as bone growth occurs. The implant acts like aflexible hinge, permitting growth at the growth plate to gradually straightenthe limb. Immediately after implantation, the patient is allowed mobilityand weight bearing. The plates and screws are made from implant qualitystainless steel conforming to ASTM F-138. |
| Indications for Use: | The Guided Growth System plates are designed for the express and solepurpose of redirecting the angle of growth of long bone(s). This is usefulfor gradually correcting angular deformities in growing children. Specificconditions/diseases for which the device will be indicated include: valgus,varus or flexion, extension deformities of the knee (femur and/or |
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K.110805
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tibia), valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
Biomechanical Testing:
In order to demonstrate that the Stainless steel Guided Growth System has the mechanical properties necessary to perform its intended use and to perform as well as the predicate device, Orthofix conducted mechanical and functional testing of the system. This testing includes tensile strength testing and stiffness calculations. The results of the testing demonstrated the Stainless Steel Guided Growth System to meet or exceed all testing requirements and to perform as well as the predicate device.
Technological Characteristics:
The Stainless Steel Guided Growth System is considered to be substantially equivalent in design, intended use and material to the predicate device. However, there are certain design differences, but these do not raise new questions regarding safety and effectiveness.
| Features | Guided Growth System - Stainless Steel |
|---|---|
| Plate/Screw Material | Implant quality stainless steel (316L) |
| Available PlateSizes | eight-Plate: 12mm; 16mmquad-Plate: 16mm; 22mm |
| Plate Geometry | Contoured waist and low profile for pediatric usage. Center hole for a temporaryguide pin to ensure accurate application of the plate. |
| Fixation Method,Screw Holes | Plates are attached to the external surface of the bone over the growth plate bybone screws two (eight-Plate) or four (quad-Plate) |
| Screw Type | Cannulated or Solid |
| Screw Length | 16mm - cannulated24mm and 32mm - cannulated and solid |
Sterilization:
The stainless steel Guided Growth System components are supplied NON-STERILE and require sterilization prior to use.
Substantial Equivalence:
Substantial equivalence is based upon design, dimension, material characterization, and biomechanical testing of the device in comparison to the predicates. The stainless steel Guided Growth System is substantially equivalent in design and function to the Growth Guidance Plate - eight-Plate (K031493 / 11/20/03) and the Guided Growth System -- quad-Plate (K093442 / 06/10/10)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Orthofix Inc. % Ms. Mary Biggers Regulatory Consultant 3451 Plano Parkway Lewisville, Texas 75056
JUN 2 1 2011
Re: K110805
Trade/Device Name: Orthofix Guided Growth System eight-Plate/quad-stainless steel (pediatric epiphysiodesis bone plates) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: OBT Dated: June 7, 2011 Received: June 9, 2011
Dear Ms. Biggers:
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
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Page 2 - Ms. Mary Biggers
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 803); good manufacturing practice requirements as sct forth in the quality systems (QS) 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/CDRHOffices/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/ReportalProblem/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,
E.I. Keith
$\sigma/$
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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V110808
INDICATION FOR USE STATEMENT
of Page
510(k) Number (if known):
Device Name:
Orthofix Guided Growth System eight-Plate/quad-Plate - stainless steel (pediatric epiphysiodesis bone plates)
Indications for Use:
The Guided Growth Plates are designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion; extension deformities of the knee (femur and/or tibia), valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
Prescription Use: _X (Per 21 CFR 801.109) Or
Over-The-Counter (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Melkerson
(Division Sign Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110805
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.