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DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System

Q: Who is the manufacturer of DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System?

Synthes (USA) Products, LLC filed the 510(k) submission for DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System (K210205).

Q: What is the FDA product code for DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System?

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 DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System?

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

Q: What are the predicate devices for DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System?

Synthes Locking Attachment Plate (K083573).

K210205 · Synthes (USA) Products, LLC · HRS · Mar 26, 2021 · Orthopedic

Device Facts

Record ID	K210205
Device Name	DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
Applicant	Synthes (USA) Products, LLC
Product Code	HRS · Orthopedic
Decision Date	Mar 26, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates and Proximal Femur Hook Plates are indicated for the treatment of periprosthetic fractures in the presence of intramedullary implants in the proximal end segment and the proximal and middle 1/3 of the diaphyseal segment of the femur, and non-unions of such fractures, in adult patients, particularly in osteoporotic and osteopenic bone. DePuy Synthes 3.5 mm VA Locking Attachment Plate is indicated to augment the stabilization of fractures, including periprosthetic fractures (Vancouver Type B when used with either the 3.5 mm VA-LCP PPFx Proximal Femur Plate or Proximal Femur Hook Plate; Vancouver Type B and C when used with other DePuy Synthes LCP plates and VA-LCP plates) and fractures in the presence of intramedullary implants, in the femur, tibia, and humerus. DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plates (when used with either 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate or the Proximal Femur Hook Plate) can be used to extend the length of a plate construct to the lateral condyles. DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Ring Attachment Plates (when used with 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate) are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy. DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Hook Plates are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy.

Device Story

System of stainless steel plates and attachment plates for periprosthetic fracture fixation; used in conjunction with intramedullary implants. Modular design allows surgeon to combine plates, hooks, and rings to stabilize fractures in proximal femur, tibia, and humerus. Operates via screw-to-plate locking or non-locking constructs using 3.5mm/4.5mm cortex and variable angle locking screws; compatible with Orthopaedic Cable System. Used by orthopedic surgeons in clinical/OR settings. Provides rigid fixation to support bone healing in osteoporotic/osteopenic patients. Output is a stabilized bone construct; aids clinical decision-making by providing modular options for complex periprosthetic fracture management.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic loading of various plate/screw constructs per ASTM F382, ASTM STP 731, and ISO 12107. MR compatibility established per ASTM F2052, F2119, F2182, F2213, and F2503. Sterility validated per ISO 11137 (SAL 10^-6). Packaging shelf life validated per ISO 11607. Biocompatibility evaluated per ISO 10993-1.

Technological Characteristics

Materials: 316L Stainless Steel. Design: Anatomically contoured modular plates with variable angle locking screw holes. Energy: None (mechanical). Connectivity: None. Sterilization: Gamma radiation. Standards: ASTM F382, ASTM STP 731, ISO 12107, ASTM F2052, F2119, F2182, F2213, F2503, ISO 11137, ISO 11607, ISO 10993-1.

Indications for Use

Indicated for adult patients with periprosthetic fractures or fractures with intramedullary implants in proximal/middle 1/3 of femur, tibia, or humerus; non-unions/malunions; greater trochanter fixation/re-attachment. Particularly for osteoporotic/osteopenic bone. Contraindicated if hip stem is loose (requires revision) or if distal fixation is not achievable for specific plate lengths.

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

Synthes Locking Attachment Plate (K083573)

Reference Devices

Synthes LCP Straight and Curved Plates (K041911, K082807, K092609, K000682)
4.5 mm LCP Proximal Femur Hook Plate (K032032)
Trochanteric Reattachment Device (K001709)
Orthopaedic Cable System (K992616)

Related Devices

K190430 — OsteoCentric Bone Plate and Screw System · Osteocentric Trauma · Mar 22, 2019
K060969 — POLYAX LOCKED PLATING SYSTEM · DePuy Orthopaedics, Inc. · May 12, 2006
K032187 — ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM · Arthrex, Inc. · Sep 22, 2003
K202489 — AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System · Advanced Orthopaedic Solutions, Inc. · Oct 26, 2020
K072818 — PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS · Smith & Nephew, Inc. · Nov 19, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized depiction of human figures. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below. March 26, 2021 Synthes (USA) products, LLC Satapa Dhamankar Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380 ## Re: K210205 Trade/Device Name: DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates and Proximal Femur Hook Plates, DePuv Synthes 3.5 mm VA Locking Attachment Plate, DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plates, DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Ring Attachment Plates, DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Hook Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: January 25, 2021 Received: January 26, 2021 Dear Satapa Dhamankar: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210205 Device Name DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System #### Indications for Use (Describe) DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates and Proximal Femur Hook Plates are indicated for the treatment of periprosthetic fractures in the presence of intramedullary implants in the proximal end segment and the proximal and middle 1/3 of the diaphyseal segment of the femur, and non-unions of such fractures, in adult patients, particularly in osteoporotic and osteopenic bone. DePuy Synthes 3.5 mm VA Locking Attachment Plate is indicated to augment the stabilization of fractures, including periprosthetic fractures (Vancouver Type B when used with either the 3.5 mm VA-LCP PPFx Proximal Femur Plate or Proximal Femur Hook Plate; Vancouver Type B and C when used with other DePuy Synthes LCP plates and VA-LCP plates) and fractures in the presence of intramedullary implants, in the femur, tibia, and humerus. DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plates (when used with either 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate or the Proximal Femur Hook Plate) can be used to extend the length of a plate construct to the lateral condyles. DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Ring Attachment Plates (when used with 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate) are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy. DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Hook Plates are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy. Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary - K210205 | Sponsor | DePuy Synthes Satapa Dhamankar 1301 Goshen Parkway West Chester, PA 19380 Phone: +1 610 719 6574 | |---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date prepared | March 23, 2021 | | Proprietary name | DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System | | Classification name | Single/multiple component metallic bone fixation appliances and accessories | | Classification | Class II Regulation Number: 21 CFR 888.3030 Product Code: HRS Common Name: Plate, Fixation, Bone | | Predicate device | Primary predicate: • Synthes Locking Attachment Plate (K083573) Additional/Reference predicates: • Synthes LCP Straight and Curved Plates (K041911, K082807, K092609, K000682) • 4.5 mm LCP Proximal Femur Hook Plate (K032032) • Trochanteric Reattachment Device (K001709) | | Device description | The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System of Stainless Steel Plates for periprosthetic fractures. It consists of plates that offer screw to plate non-locking constructs, locking constructs or a combination of both. The plates accept commercially available DePuy Synthes Stainless Steel 3.5 mm cortex screws, 3.5 mm (variable angle) locking screws, 4.5 mm cortex screws and 5.0 mm (variable angle) locking screws, as well as the Synthes Orthopaedic Cable system. The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System offers: • 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates • 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Hook Plates • 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plate • 3.5 mm VA Locking PPFx Greater Trochanter Hook Plate • 3.5 mm VA Locking PPFx Greater Trochanter Ring Attachment Plate • 3.5 mm VA Locking Attachment Plate | | Indications for use | DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates and Proximal Femur Hook Plates are indicated for the treatment of periprosthetic fractures and fractures in the presence of intramedullary implants in the proximal end segment and the proximal and middle 1/3 of the diaphyseal segment of the femur, and non-unions or malunions of such fractures, in adult patients, particularly in osteoporotic and osteopenic bone. | | | DePuy Synthes 3.5 mm VA Locking Attachment Plate is indicated to augment the stabilization of fractures, including periprosthetic fractures (Vancouver Type B when used with either the 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate or Proximal Femur Hook Plate; Vancouver Type B and C when used with other DePuy Synthes LCP plates and VA- LCP plates) and fractures in the presence of intramedullary implants, in the femur, tibia, and humerus. | | | DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plates (when used with either the 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate or the Proximal Femur Hook Plate) can be used to extend the length of a plate construct to the lateral condyles. | | | DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Ring Attachment Plates (when used with the 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate) are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy. | | | DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Hook Plates are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy. | | Contraindications | The DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plating System is contraindicated if the hip stem is loose, which requires immediate revision. | | | The DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate with 2-holes (shortest plate) is contraindicated for diaphyseal periprosthetic femoral fractures where distal fixation of the construct is not achievable. | | | The DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Hook Plate with 5 holes (shortest plate) is contraindicated for diaphyseal periprosthetic femoral fractures where distal fixation of the construct is not achievable. | | | The DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plates are contraindicated for spanning a fracture. | | Comparison to predicate | The subject device has the same intended use as the predicate device. The indications of the subject system are a subset of the indications of the predicate device. | | | The subject devices and the predicate device are metallic plates of similar design intended for bone fracture fixation. Both subject and predicate devices are anatomically contoured plates. Both subject and predicate devices have similar hole specifications and are compatible with the same screw types. Both subject and predicate devices have similar connection mechanisms for the attachment of modular plates. Both subject and predicate devices are compatible with the Orthopaedic Cable System (K992616). | | | The subject devices present the following features that are not found in the predicate device: | | | Subject devices incorporate well known and commercially available variable angle screw technology vs. the predicate devices which utilize standard locking screws | | | The subject system is a modular system, where multiple devices can be used in combination with each other to address a variety of surgeon / patient needs. | | | Subject devices offer a higher density of variable angle locking screw holes for additional fixation points | | | The subject devices are made from Stainless Steel (316L), and the predicate device is made from Stainless Steel (316L), Commercially Pure Titanium (CPTi4) or Titanium Alloy (TAN). | | | It can be concluded that the features of the subject device are substantially equivalent to the predicate device based on the similarities in intended use and design. | | Non-clinical performance data | The following performance data were provided in support of the substantial equivalence | | | Mechanical testing of a broad range of possible constructs (plates with screws) under static and dynamic loading conditions have been performed to compare the proposed DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System to the predicate device. The standards used to develop and perform mechanical testing are ASTM F382:2017, ASTM STP 731:1981 and ISO 12107-2nd Ed. The results of this testing support that the mechanical performance of the subject devices is non-inferior to that of the predicate device. | | | Magnetic Resonance compatibility testing has been performed to establish MR Conditional parameters for the subject DePuy Synthes | | | 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System. The standards used to develop and perform Magnetic Resonance compatibility testing are ASTM F2052:2015, ASTM F2119:07(2013), ASTM F2182:19e2, ASTM F2213:2017 and ASTM F2503:2013 | | | The devices in DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System are provided both sterile and non-sterile. The validations for sterile devices are performed in accordance with ANSI/AAMI/ISO 11137:2015 demonstrating a Sterility Assurance Level (SAL) of 10-6 when sterilized utilizing gamma radiation. | | | The sterile packaging shelf life of the DePuy Synthes Periprosthetic Proximal Femur Plating implants has been validated to be ten years when tested in accordance with ISO 11607-1:2020 “Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems” and ISO 11607-2:2020 “Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes.” | | | Biological safety evaluation for the devices in DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System was performed in accordance with ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process” and FDA guidance 'Use of International Standard ISO 10993-1, | | It is concluded that the information provided herein supports | | | substantial equivalence of the subject devices. | | {4}------------------------------------------------ {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------