The Flower Upper Extremity Plating Set is intended to be used for fixation of fractures, fusions, or osteotomies of the clavicle, humerus, radius and ulna.

Device Description

The Flower Upper Extremity Plating Set consists of the following components and accessories: midshaft clavicle plates, distal clavicle plates, medial distal humerus plates, lateral distal humeral plates, posterior lateral distal humerus plates, olecranon plates, variable angle locking screws, variable angle non-locking screws. The plates are all made of pure titanium compliant with ASTM F67, the screws are made of titanium alloy compliant with ASTM F136. The system accepts locking and non-locking screws cleared via K123562 and K131657, the locking and non-locking screws included in this submission extend the length range of the previously cleared screws. The device is provided with general purpose instruments, including appropriately sized trials.

AI/ML Overview

The provided FDA 510(k) summary for the Flower Upper Extremity Plating Set describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document primarily focuses on regulatory approval based on design and material equivalence to existing devices and adherence to general performance standards, rather than a clinical study evaluating its performance against specific acceptance criteria in a patient population.

Therefore, much of the requested information about clinical study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document as it pertains to a pre-market clinical performance evaluation, which is not the focus of this 510(k) summary for this type of device.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Criteria	Acceptance Criteria	Reported Device Performance
Material Compliance	Compliance with specified ASTM/ISO standards for pure titanium and titanium alloy.	The plates are made of pure titanium compliant with ASTM F67 (ISO 5832-2). The screws are made of titanium alloy compliant with ASTM F136 (ISO 5832-3).
Biocompatibility	Compliance with ISO 10993 series for biological evaluation.	Compliance with ISO 10993-1 (risk management process for evaluation and testing) and ISO 10993-5 (in vitro cytotoxicity). (Implied that the device passed these tests given the substantial equivalence claim).
Sterilization	Compliance with ISO 11137-1 for radiation sterilization.	Compliance with ISO 11137-1. (Implied that the device passed these tests given the substantial equivalence claim).
Mechanical Strength (Engineering Analysis)	Appropriate mechanical strength for the claimed intended use.	An engineering analysis was performed to demonstrate appropriate mechanical strength. The device functioned as intended.
Functionality	Device functions as intended.	The Flower Upper Extremity Plating Set functioned as intended.
Substantial Equivalence	Device is substantially equivalent to predicate devices.	The device is substantially equivalent to the identified predicate devices in intended uses/indications, technological characteristics, and principles of operation. Claims no new risks.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No clinical test set or patient data is mentioned in this 510(k) summary. The "testing" primarily refers to material, biocompatibility, and sterilization standards, and an engineering analysis, not clinical performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for this submission is based on adherence to recognized material and performance standards and comparison to predicate devices, not on expert consensus from clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring adjudication.

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 metallic bone fixation appliance, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical fixation device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" here is compliance with recognized engineering, material, and biocompatibility standards (e.g., ASTM F67, F136, ISO 10993, ISO 11137), and the established performance and safety profiles of the cited predicate devices.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device submission.

9. How the ground truth for the training set was established

Not applicable, as no training set is relevant here.

In summary:

This 510(k) notification for the Flower Upper Extremity Plating Set demonstrates substantial equivalence based on bench testing, material conformity, and design similarity to already approved devices. It does not involve a clinical study with patient data, expert reviews, or AI performance metrics as it's a traditional implantable medical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 15, 2014

Flower Orthopedics Corporation Mr. Gary Barnett RA/RQ Manager 100 Witmer Road, Suite 280 Horsham, Pennsylvania 19044

Re: K142306 Trade/Device Name: Flower Upper Extremity Plating Set Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 15, 2014 Received: August 19, 2014

Dear Mr. Barnett:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Gary Barnett

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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Lori A. Wiggins -S

for

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

510(k) Number (if known): K142306

Device Name: Flower Upper Extremity Plating Set

Indications for Use:

The Flower Upper Extremity Plating Set is intended to be used for fixation of fractures, fusions, or osteotomies of the clavicle, humerus, radius and ulna.

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)

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510(k) SUMMARY

Flower Orthopedics Corporation's Upper Extremity Plating Set

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Flower Orthopedics Corporation 100 Witmer Road. Suite 280 Horsham PA 19044

(215) 394-8903 Phone: Facsimile: (215) 394-8904

Contact Person: Gary Barnett Date Prepared: August 15, 2014

Name of Device

Flower Upper Extremity Plating Set

Common or Usual Name/Classification Name

The Flower Upper Extremity Plating Set consists of bone 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

Acumed Inc., Congruent Bone Plating System (K012655, K063640, K071715) Flower Orthopedics, Small and Medium Implant Set (K123562, K131657)

Intended Use / Indications for Use

The Flower Upper Extremity Plating Set is intended to be used for fixation of fractures, fusions, or osteotomies of the clavicle, humerus, radius and ulna.

Device Description

Technological Characteristics

The Flower Upper Extremity Plating Set consists of the following components/configurations: Midshaft Clavicle Plates, with a width of 11 mm and lengths of 70/110 mm; Distal Clavicle Plates, with a width of 11 mm and lengths of 91/136 mm;

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Medial Distal Humerus Plates, with a width of 11 mm and lengths of 78/140 mm; Lateral Distal Humerus Plates, with a width of 11 mm and lengths of 87/146 mm: Posterior Lateral Distal Humerus Plates, with a width of 11 mm and lengths of 100/148 mm; Olecranon Plates, with a width of 10 mm and lengths of 95/135 mm; Coronoid Plates, with a width of 21 mm, and 40mm lengths; Variable Angle Locking Screws: 2.7 mm, 3.0 mm, 3.5 mm, 4.0 mm dia. x 65 mm long: Variable Angle Non-Locking Screws: 2.7 mm. 3.0 mm. 3.5 mm dia. X 8 mm long: Variable Angle Non-Locking Screws: 2.7 mm. 3.0 mm dia. X 60 mm long Variable Angle Non-Locking Screws: 2.7 mm, 3.0 mm, 3.5 mm, 4.0 mm dia. X 65 mm long

Performance Data

The Flower Upper Extremity 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 Alloy for Surgical Implant Applications
o ISO 5832-3, Implants for Surgery. Metallic materials. Part 3: Wrought titanium 6-aluminium 4vanadium allov:
o 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;
o 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 upper extremity plates provide appropriate mechanical strength for the claimed intended use.

In all instances, the Flower Upper Extremity 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 Upper Extremity 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 Upper Extremity Plating Set provide appropriate mechanical strength for the claimed intended use. Thus, the subject upper extremity plates are substantially equivalent and do not present any new risks.

Regulation Number and Section

§ 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.