Who is the manufacturer of SCHUHLI IMPLANT SYSTEM?

Synthes (Usa) filed the 510(k) submission for SCHUHLI IMPLANT SYSTEM (K954963).

What is the FDA product code for SCHUHLI IMPLANT SYSTEM?

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

What is the regulatory pathway for SCHUHLI IMPLANT SYSTEM?

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

What are the predicate devices for SCHUHLI IMPLANT SYSTEM?

Synthes Dynamic Compression Plates and screws (K954763).

Who can help prepare an FDA 510(k) submission like SCHUHLI IMPLANT SYSTEM?

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.

SCHUHLI IMPLANT SYSTEM

K954963 · Synthes (Usa) · HRS · Mar 22, 1996 · Orthopedic

Device Facts

Record ID	K954963
Device Name	SCHUHLI IMPLANT SYSTEM
Applicant	Synthes (Usa)
Product Code	HRS · Orthopedic
Decision Date	Mar 22, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Schuhli Implant System is intended for use with Synthes long bone and small bone plates and screws. The Schuhli Assembly locks the screw to the plate (independent of bone contact) and has the potential to decrease the possibility of the screw loosening and backing out of the bone. The devices are designed for, but are not limited to, use in osteoporotic bone for unicortical (of the far cortex) or bicortical fixation in cases of trauma, tumor, or infection, and as fixed angle devices (where the angle between two supporting members is fixed).

Device Story

System comprises nut, washer, and temporary holding screw; used with Synthes long/small bone plates and screws. Nut features spikes for bone engagement; assembly locks screw to plate independent of bone contact to prevent loosening/backing out. Used by surgeons in clinical settings for unicortical or bicortical fixation. Benefits include enhanced stability in osteoporotic bone. Provided sterile via gamma radiation.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: Titanium or stainless steel. Sizes: 3.5 mm and 4.5 mm. Components: Nut, washer, temporary holding screw. Sterilization: Gamma radiation. Locking mechanism: Screw-to-plate fixation independent of bone contact.

Indications for Use

Indicated for patients requiring internal fixation of long and small bone fractures, including osteoporotic bone, in cases of trauma, tumor, or infection. Contraindicated for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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 Dynamic Compression Plates and screws (K954763)

Related Devices

K980944 — SYNTHES SCHUHLI IMPLANT SYSTEM · Synthes (Usa) · Apr 27, 1998
K090975 — DEROYAL NON-LOCKING BONE FIXATION SYSTEM · Deroyal Industries, Inc. · Apr 12, 2010
K033669 — SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) · Smith & Nephew, Inc. · Dec 10, 2003
K143188 — 3.Omm Biomet Cannulated Screw System · Biomet Manufacturing Corp · Dec 30, 2014
K130614 — BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS · Laura Cattabriga · Jan 17, 2014

Submission Summary (Full Text)

{0} P. 006 K954763 MAR 22 Attachment 3: Summary of Safety and Effectiveness Information [510(k) Summary] | Synthes (USA) | Contact Name: | | --- | --- | | 1690 Russell Road | Angela Silvestri | | Paoli, PA 19301 | (610) 647-9700 | | | October 27, 1995 | Device Name: Synthes Schuhli Implant System is compared to Synthes Dynamic Compression Plates and screws. The Schuhli Implant System is intended for use with Synthes long bone and small bone plates and screws. The Schuhli Assembly locks the screw to the plate (independent of bone contact) and has the potential to decrease the possibility of the screw loosening and backing out of the bone. The devices are designed for, but are not limited to, use in osteoporotic bone for unicortical (of the far cortex) or bicortical fixation in cases of trauma, tumor, or infection, and as fixed angle devices (where the angle between two supporting members is fixed). The Schuhli Implant System consists of a nut, a washer, and a temporary holding screw. The nut fits into the underside of the plate and has spikes which secure the nut to bone. The temporary holding screw is used to hold the Schuhli to the plate (before the screws are placed) while the surgeon obtains the correct placement of the plate. The washer fits into the plate's screw hole, accepting the head of a screw. The Schuhli Implant System is available in two sizes (4.5 mm and 3.5 mm); each size is available in either titanium or stainless steel, and is used with either titanium or stainless steel compression plates and screws, respectively. WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. Synthes Schuhli Implant System will be provided to the user sterile. Gamma radiation will be used to sterilize the device. Based on mechanical test results, the Schuhli Implant System is substantially equivalent to Synthes Dynamic Compression Plates and screws.