(49 days)
No
The device description and intended use are for a set of bone plates and screws for ankle fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical strength and material standards.
Yes
The device is described as "Ankle Plating Set" intended for fixation of the ankle in adults and adolescents for various conditions like osteotomies, fractures, and nonunions, which are all therapeutic interventions.
No
Explanation: The device, the Flower Ankle Plating Set, is a surgical implant designed for fixation of the ankle in cases of fractures, nonunions, malunions, and osteotomies. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists physical components made of titanium (plates and screws) and general-purpose instruments, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a set of metal plates and screws intended for surgical implantation to fix bones in the ankle. This is a surgical implant, not a device used for testing biological samples.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or procedures for analyzing biological samples, which are hallmarks of IVD devices.
The Flower Ankle Plating Set is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The Flower Ankle Plating Set is intended for use for fixation of the ankle in adults and adolescents (12-21) in whom the growth plates have fused, and particularly in osteopenic bone. Specifically.
- . Distal Medial and Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
- . Distal Tibia A-Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
- . Straight and Distal Lateral Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Flower Ankle Plating Set consists of the following components and accessories: distal medial tibia plates, distal lateral tibia plates, distal tibia A-plate, straight fibula plate, distal lateral fibula plate, all made of pure titanium compliant with ASTM F67. The system accepts locking and non-locking screws cleared via K123562 and K131657. The device is provided with general purpose instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle, distal tibia, distal fibula
Indicated Patient Age Range
adults and adolescents (12-21) in whom the growth plates have fused
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)
The Flower Ankle Plating Set was tested (worse case) according to the following standards:
- . ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications
- . ISO 5832-2. Implants for Surgery, Metallic Materials. Part 2: Unalloyed Titanium
- . ASTM F136, Standard Specification for Wrought Titanium- 6 Aluminum- 4 Vanadium ELI Allov for Surgical Implant Applications
- ISO 5832-3, Implants for Surgery. Metallic materials. Part 3: Wrought titanium 6-. aluminium 4-vanadium allov:
- ISO 7153-1. Surgical instruments Metallic materials Part 1: Stainless steel (ISO . 7153-1:1991, including Amendment 1:1999); German version EN ISO 7153-1:2000;
- . ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process;
- . ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
- ISO 11137-1. Sterilization of health care products Radiation Part 1: . Requirements for development, validation and routine control of a sterilization process for medical devices. (Sterility)
In addition, an engineering analysis was performed to demonstrate that the subject ankie plates provide appropriate mechanical strength for the claimed intended use.
In all instances, the Flower Ankle Plating Set functioned as intended and test results, as well as an engineering analysis, demonstrate substantial equivalence with the cited predicate devices.
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.
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.
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
§ 888.3030 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.
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NOV 1 8 2013
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K133102
510(k) SUMMARY
Flower Orthopedics Corporation's Ankle Plating Set
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Flower Orthopedics Corporation 7715 Crittenden Street, #413 Philadelphia, PA 19118
Phone: (267) 437 3063 (267) 437 3072 Facsimile:
Contact Person: Oliver Burckhardt, Chief Executive Officer Date Prepared: September 30, 2013
Name of Device
Flower Ankle Plating Set
Common or Usual Name/Classification Name
The Flower Ankle Plating Set consists of bone ankle plates classified under product code HRS (21 C.F.R. 888.3030, Single/multiple component metallic bone fixation appliance and accessories: Class II) and bone fixation screws classified under product code HWC (21 C.F.R. 888.3040, Smooth or threaded metallic bone fixation fastener; Class II).
Predicate Devices
Synthes USA, Synthes 2.7mm/3.5mm LCP Distal Fibula Plates (K083213) Synthes USA, Synthes Variable Angle LCP Ankle Trauma System (K120854) Synthes USA, Synthes 2.7/3.5mm Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plates (K121601) Flower Orthopedics Corporation, Flower Small and Medium Implants Set (K123562 and K131657)
Intended Use / Indications for Use
The Flower Ankle Plating Set is intended for use for fixation of the ankle in adults and adolescents (12-21) in whom the growth plates have fused, and particularly in osteopenic bone. Specifically.
- . Distal Medial and Lateral Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
- . Distal Tibia A-Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
- . Straight and Distal Lateral Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
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Device Description
The Flower Ankle Plating Set consists of the following components and accessories: distal medial tibia plates, distal lateral tibia plates, distal tibia A-plate, straight fibula plate, distal lateral fibula plate, all made of pure titanium compliant with ASTM F67. The system accepts locking and non-locking screws cleared via K123562 and K131657. The device is provided with general purpose instruments.
Technological Characteristics
The Flower Ankle Plating Set consists of the following components/configurations:
- Distal Medial Tibia Plates with a width of 11mm and a length range of 107mm-� 179mm:
- Distal Lateral Tibia Plates with a width of 11mm and a length range or 81mm-. 141mm;
- . Distal Tibia A-Plate with a width of 11mm and length of 65mm;
- Straight Fibula Plates with a width of 11mm and a length range of 45mm-86mm; and .
- Distal Lateral Fibula Plates with a width of 11mm and length range of 84mm-180mm. .
Performance Data
The Flower Ankle Plating Set was tested (worse case) according to the following standards:
- . ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications
- . ISO 5832-2. Implants for Surgery, Metallic Materials. Part 2: Unalloyed Titanium
- . ASTM F136, Standard Specification for Wrought Titanium- 6 Aluminum- 4 Vanadium ELI Allov for Surgical Implant Applications
- ISO 5832-3, Implants for Surgery. Metallic materials. Part 3: Wrought titanium 6-. aluminium 4-vanadium allov:
- ISO 7153-1. Surgical instruments Metallic materials Part 1: Stainless steel (ISO . 7153-1:1991, including Amendment 1:1999); German version EN ISO 7153-1:2000;
- . ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process;
- . ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity;
- ISO 11137-1. Sterilization of health care products Radiation Part 1: . Requirements for development, validation and routine control of a sterilization process for medical devices. (Sterility)
In addition, an engineering analysis was performed to demonstrate that the subject ankie plates provide appropriate mechanical strength for the claimed intended use.
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K133102
In all instances, the Flower Ankle Plating Set functioned as intended and test results, as well as an engineering analysis, demonstrate substantial equivalence with the cited predicate devices.
Substantial Equivalence
The Flower Ankle Plating Set is substantially equivalent to the identified predicate devices. The subject devices have the same intended uses/indications, technological characteristics, and principles of operation as the predicate devices. An engineering analysis was performed to demonstrate that the components in the Flower Ankle Plating Set provide appropriate mechanical strength for the claimed intended use. Thus, the subject ankle plates are substantially equivalent.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Flower Orthopedics Corporation % Ms. Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103 November 18, 2013
Re: K133102
Trade/Device Name: Flower Ankle Plating Set Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: September 30, 2013 Received: September 30, 2013
Dear Ms. Hogan:
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. Iisting 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
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Page 2 - Ms. Janice M. Hogan
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 set 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark Nighterson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K133102 510(k) Number (if known):
Device Name: Flower Ankle Plating Set
Indications for Use:
The Flower Ankle Plating Set is intended for use for fixation of the ankle in adults and adolescents (12-21) in whom the growth plates have fused, and particularly in osteopenic bone. Specifically,
- Distal Medial and Lateral Tibia Plates are intended for fixation of osteotomies, . fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
- Distal Tibia A-Plates are intended to buttress partial articular fractures and bone . fragments of the distal tibia, and
- . Straight and Distal Lateral Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices
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