LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF

Q: Who is the manufacturer of LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF?

Aap Implantate AG filed the 510(k) submission for LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF (K113648).

Q: What is the FDA product code for LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF?

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

Q: What is the regulatory pathway for LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K113648 · Aap Implantate AG · HRS · Sep 6, 2012 · Orthopedic

Device Facts

Record ID	K113648
Device Name	LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF
Applicant	Aap Implantate AG
Product Code	HRS · Orthopedic
Decision Date	Sep 6, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The aap LOQTEQ Large Fragment Set is intended for: Fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation of non-unions or malunions.

Device Story

The aap LOQTEQ Large Fragment Set is an orthopedic implant system for bone fracture fixation. It comprises titanium bone plates (narrow and broad 4.5) and screws (4.5 mm cortical and locking). The system functions as an internal fixator when plates are used with locking screws. It is used by surgeons in clinical settings to stabilize bone fragments, treat fractures, and address non-unions or malunions. The device provides mechanical support to bone structures, facilitating healing and restoring skeletal integrity. The set includes specialized instruments for surgical implantation.

Clinical Evidence

Bench testing only. Static and dynamic 4-point-bending tests of bone plates were performed according to ASTM F 382-99 to demonstrate mechanical performance and substantial equivalence.

Technological Characteristics

Plates: cp Titanium (ASTM F67 or ISO 5832-2). Screws: Ti6Al4V (ASTM F136 or ISO 5832-3). System includes 4.5 mm narrow/broad plates and 4.5 mm cortical/locking screws. Mechanical fixation via internal fixator principle. No software or electronic components.

Indications for Use

Indicated for fixation of long bones (humerus, femur, tibia), osteopenic bone, non-unions, and malunions in patients requiring bone fracture stabilization.

Regulatory Classification

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.

Predicate Devices

Large Fragment LCP Instrument and Implant Set of Synthes (USA) (K000682)

Related Devices

K113652 — LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T · Aap Implantate AG · Aug 30, 2012
K133675 — AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5 · Aap Implantate AG · Jan 23, 2014
K113602 — AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM · Aap Implantate AG · Oct 31, 2012
K221088 — Anatomic Bone Plate · Double Medical Technology, Inc. · Jan 18, 2023
K123562 — FLOWER SMALL AND MEDIUM BONE IMPLANTS · Flower Orthopedics Corporation · Mar 29, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ oap Implantate AG aap LOQTEQ Large Fragment Set Summary of Safety and Effectiveness ## . . . 2 PAGE ﺎ ﭘﺎ | Sponsor: | aap Implantate AG Lorenzweg 5 D-12099 Berlin Germany | | | SEP 6 2012 | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|------------| | Company Contact: | Dipl.-Ing. Marc Seegers Phone:+49-30-750-19 -192 Fax: +49-30-750-19 - 111 | | | | | Date | December 5, 2011 | | | | | Trade Name: | aap LOQTEQ® Large Fragment Set | | | | | Common Name: | Large Fragment Set | | | | | Classification: | | | | | | Classification Name and Reference: | 21 CFR 888.3030 Single/multiple com-ponent metallic bone fixation appliances and accessories - Class II and 21 CFR 888.3040 Smooth or threaded metallic bone fixation fas- tener - Class II | | | | | Device Product Code and Panel Code: | Orthopedics/87/ HRS: Plate, Fixation, Bone Orthopedics/87/ HWC: Screw, Fixation, Bone | | | | | Predicate device: | Large Fragment LCP Instrument and Implant Set of Synthes (USA) under the premarket notification K000682 (May - 1, 2000). At this time the system was called Synthes Large Frag- ment Dynamic Compression Locking (DCL) System. | | | | | Device Description: | Bone plates and screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries. Bone plates are fixed by the use of bone screws. Bone plates and bone screws are implants. If the plates are used in conjunc- tion with locking screws, a so called internal fixator will be real- ized (internal fixation). The LOQTEQ® Large Fragment Set con- sists of: • LOQTEQ® Narrow Plate 4.5, • LOQTEQ® Broad Plate 4.5, • LOQTEQ® Cortical Screw 4.5, T25, self-tapping • Cortical Screw 4.5, self-tapping • Set of Instruments, Large Fragment Set | | | | | Material: | Plates are made of cp Titanium (ASTM F67 or ISO 5832-2) Screws are made of Ti6Al4V (ASTM F136 or ISO 5832-3) | | | | {1}------------------------------------------------ | Indications: | The aap LOQTEQ® Large Fragment Set is intended for: Fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation of non-unions or malunions. | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Substantial Equivalence: | The Substantial Equivalence of the new device and the predicate device is based on similar intended use, design, functionality, components and materials in use. | | | Documentation including mechanical testing to show the sub- stantial equivalence and safety and effectiveness has been pro- vided with this submission. | | Performance Data (Non-Clinical and / or Clinical): | Non-clinical tests have been performed and show the effectiveness and safety of the device. | | | Summary of Non-clinical tests: | | | Type of test: | | | Static and dynamic 4-point-bending test of bone plates accord- ing to ASTM F 382-99. | | | Assessment of test results: | | | Substantial equivalence with respect to the mechanical perfor- mance of the aap plates could be stated due to the test results gained. The subject device is safe and effective, and whose per- formance meets the requirements of its pre-defined acceptance criteria and intended uses. | | | Documentation regarding the mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission. | {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002 SEP 6 2012 aap Implante AG % Mr. Marc Seegers, Dipl.-Ing., Director QA/RA Lorenzweig 5 D-12099 Berlin Germany Re: K113648 Trade/Device Name: aap LOQTEQ Large Fragment Set Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS. HWC Dated: August 13, 2012 Received: August 15, 2012 Dear Mr. Seegers: 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 {3}------------------------------------------------ Page 2 - Mr. Marc Seegers forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Erind Keith Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ aap Implantate AG LOQTEQ Large Fragment Set ## Indications for Use Statement 510(k) Number (if known): ## Device Name: LOQTEQ Large Fragment Set ## Indications for Use: The aap LOQTEQ Large Fragment Set includes Narrow and Broad Plates 4.5. The plates accept 4.5 mm locking screws and 4.5 mm cortical screws. The aap LOQTEQ Large Fragment Set is intended for: Fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation of non-unions or malunions. 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) .H. Boyle Sr. mxm Division of Surgical, Orthopedic, and Restorative Devices Page _1_ of _1_ f*1* 510(k) Number K113648