The Flower Small and Medium Implants set is intended for use for internal fixation of fractures and reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, hand and foot in adults and for long bone in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions.

This system can be used for palmar, ventral, dorsal or orthogonal application.

Device Description

The Flower Small and Medium Implants set consists of the following components and accessories: pure titanium small straight plates, small and medium reconstruction plates, medium osteosynthesis plates, proximal humerus plates, distal radius plates, L-shaped plates, T-plates, angular T-shaped plates, H-shaped plates, mediocarpal plate; and titanium alloy screws. The device is also provided with general purpose instruments.

AI/ML Overview

This submission is for a medical device called the "Flower Small and Medium Implant Set," which is a bone plating system. It's a 510(k) premarket notification for modifications to an already cleared device (K123562).

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

Acceptance Criteria	Reported Device Performance
Mechanical Strength for Intended Use (Implicit, based on substantial equivalence to predicate devices)	Adequate and Substantially Equivalent Mechanical Strength. The submission states that "Flower Orthopedics has conducted engineering analysis to demonstrate that the modifications to the Flower Small and Medium Implants set provides adequate and substantially equivalent mechanical strength for its intended use." This is considered sufficient to demonstrate compliance by the FDA for the purpose of 510(k) clearance, as it addresses the primary functional requirement for bone plating systems.

Acceptance Criteria

Reported Device Performance

Mechanical Strength for Intended Use (Implicit, based on substantial equivalence to predicate devices)

Adequate and Substantially Equivalent Mechanical Strength. The submission states that "Flower Orthopedics has conducted engineering analysis to demonstrate that the modifications to the Flower Small and Medium Implants set provides adequate and substantially equivalent mechanical strength for its intended use." This is considered sufficient to demonstrate compliance by the FDA for the purpose of 510(k) clearance, as it addresses the primary functional requirement for bone plating systems.

2. Sample size used for the test set and the data provenance

The provided text does not mention a clinical study or a test set involving patients or medical images. The performance data is based on "engineering analysis." Therefore, sample size and data provenance in the context of clinical or imaging data are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical or image-based ground truth was established as there was no test set or clinical study. The ground truth for this device's performance is derived from engineering principles and comparison to predicate devices, rather than expert consensus on diagnostic interpretations.

4. Adjudication method for the test set

Not applicable. No test set was used that required expert 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 is a submission for a bone plating system, not an AI-powered diagnostic device. Therefore, an MRMC study is not relevant to its clearance.

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

Not applicable. This device is not an algorithm or an AI system.

7. The type of ground truth used

The "ground truth" for the device's acceptable performance is based on engineering analysis and comparison to the mechanical properties of legally marketed predicate devices. The implicit ground truth is that if the modified device possesses "adequate and substantially equivalent mechanical strength" to its predicates, it meets the safety and effectiveness requirements.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "training" for the device's design and engineering would be the existing knowledge and data from predicate devices and biomechanical principles, but not in the context of a "training set" for an algorithm.

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

Not applicable. As there is no training set mentioned, the method for establishing its ground truth is also not applicable.

Summary

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5.510(K) SUMMARY

Submitter's Name:	Flower Orthopedics Corporation
Submitter's Address:	7715 Crittenden Street, #413Philadelphia, PA 19118
Submitter's Telephone:	267-437-3063
Submitter's Fax:	267-437-3072
Authorized Contact Name:	Janice M. Hogan
Contact's Telephone:	267-675-4611
Contact's Email:	janice.hogan@hoganlovells.com
Date Summary wasPrepared:	July 26, 2013
Trade or Proprietary Name:	Flower Small and Medium Implant Set
Common or Usual Name:	Bone plating system
Classification:	Class II per 21 CFR §888.3030
Product Codes:	HRS, HWC
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate Devices:	Flower Small and Medium Implant Set (K123562)Synthes USA's 3.5 mm and 4.5 mm LockingCompression Plate (LCP) System withExpanded Indications (K082807)Stryker's VariAx Distal Radius Locked Plating SystemLine Extension for Addition of Aiming Blocks(K112455)KLS-Martin Hand Plating System (K040598)

CHANGE FROM PREDICATE:

The purpose of this submission is to make modifications (line extensions) to the components of the Flower Small and Medium Implant Set cleared in K123562. The standard construct is modified by adding sizes not included in the previous submission.

TECHNOLOGICAL CHARACTERISTICS:

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INDICATIONS FOR USE

This system can be used for palmar, ventral, dorsal or orthogonal application.

Performance Data

In support of this 510(k) Premarket Notification, Flower Orthopedics has conducted engineering analysis to demonstrate that the modifications to the Flower Small and Medium Implants set provides adequate and substantially equivalent mechanical strength for its intended use.

CONCLUSION

The Flower Small and Medium Implants system is very similar to previously cleared Flower Small and Medium Implant Set. The Flower Small and Medium Implants system has the same intended uses and similar indications, technological characteristics, and principles of operation as the previously cleared devices. The minor technological differences between the subject Flower Small and Medium Implants and its previously cleared devices raise no new types of safety or effectiveness questions. The overall technology characteristics lead to the conclusion that Flower Small and Medium Implant Set is substantially equivalent to the previously cleared devices.

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

August 22, 2013

Flower Orthopedics Corporation % Ms. Janice M. Hogan Partner Hogan Lovells US LLP 1835 Market Street. 29th Floor Philadelphia, Pennsylvania 19103

Re: K131657

Trade/Device Name: Flower Small and Medium Implant 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: July 26, 2013 Received: July 26, 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, 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

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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/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/ReportalProblem/default.hun 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 -S

Mark N. Melkerson Director Division of Orthopedic Devices . Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT

Device Name: Flower Small and Medium Implant Set

This system can be used for palmar, ventral, dorsal or orthogonal application.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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)

Elizabeth L. Frank -S

Division of Orthopedic Devices

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.