K Number
K123562
Device Name
FLOWER SMALL AND MEDIUM BONE IMPLANTS
Date Cleared
2013-03-29

(130 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 use in long bones in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extraaticular 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, T-plates, angular T-shaped plates, H-shaped plates, mediocarpal plate; and titanium alloy screws. The device is also provided with general purpose instruments. All plates are made of pure titanium (ISO 5832-2). The Flower Small and Medium Implants set provides fixed-angle lockable screws and plates to assist with internal fixation of fractures and reconstruction of bones. The principles of operation of the device are similar to other bone plating systems. The plates are comprised of various shapes. alignments, thicknesses, widths, and lengths designed to contour to different bones and locations on the body for internal fixation or reconstruction following fracture. .Each of the plates contains several locking holes that allow for the insertion of Flower Small and Medium Implants locking screws. To use the Flower Small and Medium Implants set, the surgeon first selects an implant of the appropriate size and shape based on the intended site of use. The plate should be placed in an appropriate location on the given bone or anatomical location in need of repair.
More Information

No
The 510(k) summary describes a system of bone plates and screws for internal fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The device's operation is described as similar to other bone plating systems, which are purely mechanical.

No
The device is described as an internal fixation system for fractures and bone reconstruction, which is a structural and mechanical intervention, not a therapeutic treatment.

No
The device is described as an implant set for internal fixation of fractures and bone reconstruction, which are therapeutic rather than diagnostic applications.

No

The device description clearly states it consists of physical components like plates, screws, and instruments made of titanium and titanium alloy, which are hardware.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "internal fixation of fractures and reconstruction of bones." This is a surgical procedure performed directly on the patient's body.
  • Device Description: The device consists of "pure titanium small straight plates, small and medium reconstruction plates, medium osteosynthesis plates, proximal humerus plates, distal radius plates, T-plates, angular T-shaped plates, H-shaped plates, mediocarpal plate; and titanium alloy screws." These are implants designed to be surgically placed within the body.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.

The device is a surgical implant used for orthopedic procedures, not an in vitro diagnostic test.

N/A

Intended Use / Indications for Use

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 use in long bones in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extraaticular fractures, displaced fractures, osteotomies, non-unions and mal-unions.

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

Product codes

HRS, HWC

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, T-plates, angular T-shaped plates, H-shaped plates, mediocarpal plate; and titanium alloy screws. The device is also provided with general purpose instruments. All plates are made of pure titanium (ISO 5832-2).

The Flower Small and Medium Implants set provides fixed-angle lockable screws and plates to assist with internal fixation of fractures and reconstruction of bones. The principles of operation of the device are similar to other bone plating systems. The plates are comprised of various shapes. alignments, thicknesses, widths, and lengths designed to contour to different bones and locations on the body for internal fixation or reconstruction following fracture. Each of the plates contains several locking holes that allow for the insertion of Flower Small and Medium Implants locking screws. To use the Flower Small and Medium Implants set, the surgeon first selects an implant of the appropriate size and shape based on the intended site of use. The plate should be placed in an appropriate location on the given bone or anatomical location in need of repair.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, hand and foot, long bones

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)

  • Biocompatibility in accordance with ISO 10993-1, ISO 10993-5 was established, demonstrating that the materials are non-cytotoxic and biocompatible.
  • Sterilization validation of implants and instruments demonstrated assurance level of 10° for this method of sterilization using the specified gamma sterilization cycle.
  • Packaging validation and shelf life testing ensured that the packaging can maintain its physical integrity and maintain a sterile barrier over the stated period.
  • Engineering analysis has been performed to demonstrate that the Flower Small and Medium Implants system provides appropriate mechanical strength for its intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K082807, K092609, K112455, K040598, K103243

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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.

0

K123562 page 1/3

510(k) SUMMARY

MAR 2 9 2013

Flower Orthopedics Corporation's Flower Small and Medium Implants

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

Flower Orthopedics Corporation 7715 Crittenden Street, #413 Philadelphia, PA 19118

Phone: +1 267 437 3063 Facsimile: +1 267 437 3072

Contact Person: Oliver B. Burckhardt

Date Prepared: March 29, 2013

Name of Device and Name/Address of Sponsor

Flower Small and Medium Implants

Common or Usual Name

Bone plating system

Classification Name/ Product Code

Classification Name: 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliance and accessories

Product Codes: HRS (Plate, Fixation, Bone), HWC (Screw, Fixation, Bone)

Predicate Devices

  • Synthes USA's 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications (K082807)
  • Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad Locking Compression Plates (LCP) (K092609)
  • Stryker's VariAx Distal Radius Locked Plating System Line Extension for Addition of Aiming Blocks (K112455)

KLS-Martin Hand Plating System (K040598)

Synthes 2.4mm VA-LCP Intercarpal Fusion System (K103243)

1

Intended Use / Indications for Use

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 use in long bones in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extraaticular fractures, displaced fractures, osteotomies, non-unions and mal-unions.

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

Technological Characteristics

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, T-plates, angular T-shaped plates, H-shaped plates, mediocarpal plate; and titanium alloy screws. The device is also provided with general purpose instruments. All plates are made of pure titanium (ISO 5832-2).

The Flower Small and Medium Implants set provides fixed-angle lockable screws and plates to assist with internal fixation of fractures and reconstruction of bones. The principles of operation of the device are similar to other bone plating systems. The plates are comprised of various shapes. alignments, thicknesses, widths, and lengths designed to contour to different bones and locations on the body for internal fixation or reconstruction following fracture. .Each of the plates contains several locking holes that allow for the insertion of Flower Small and Medium Implants locking screws. To use the Flower Small and Medium Implants set, the surgeon first selects an implant of the appropriate size and shape based on the intended site of use. The plate should be placed in an appropriate location on the given bone or anatomical location in need of repair.

Performance Data

In support of this 510(k) Premarket Notification, Flower Orthopedics has conducted the following testing. In all instances, the Flower Small and Medium Implants set functioned as intended.

  • Biocompatibility in accordance with ISO 10993-1, ISO 10993-5 was established, demonstrating . that the materials are non-cytotoxic and biocompatible.
  • . Sterilization validation of implants and instruments demonstrated assurance level of 10° for this method of sterilization using the specified gamma sterilization cycle.
  • Packaging validation and shelf life testing ensured that the packaging can maintain its physical . integrity and maintain a sterile barrier over the stated period.

Substantial Equivalence

The Flower Small and Medium Implants system is very similar to Synthes's 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications (K082807), the Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad Locking Compression Plates (LCP) (K092609), Stryker's VariAx Distal Radius Locked Plating System Line Extension for Addition of Aiming Blocks (K112455), KLS-Martin's Hand Plating System (K040598), and Synthes 2.4mm VA-LCP Intercarpal Fusion System (K103243). The Flower Small and Medium Implants system has the same intended

2

uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The overall surgical procedure for the Flower Small and Medium Implants set and the predicate devices are very similar and there are no new types of safety or effectiveness concerns. The minor difference in the locking feature between the Flower system and the predicate systems do not significantly alter the surgical technique. The minor technological differences between the Flower Small and Medium Implants and its predicate devices, e.g., minor differences in the range of available geometries and dimensions, raise no new types of safety or effectiveness questions because these size differences are very minor and are largely encompassed within the range of similar parameters in the predicate devices. Engineering analysis has been performed to demonstrate that the Flower Small and Medium Implants system provides appropriate mechanical strength for its intended use. Thus, the Flower Small and Medium Implants system is substantially equivalent.

3

Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: March 29, 2013

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

Re: K123562

Trade/Device Name: Flower Small and Medium Implants 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: March 1, 2013 Received: March 1, 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 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

4

Page 2 -Ms. Janice M. Hogan

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/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 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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Indications for Use Statement

K123562 510(k) Number (if known):

Device Name: Flower Small and Medium Implants

Indications for Use:

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 use in long bones in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extraaticular fractures, displaced fractures, osteotomies, non-unions and mal-unions.

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

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Krishna R 2013.03.2

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