← Product Code [HRS](/productcode/HRS) · K942032 # PLAMP, PLAMP PLATE, PLAMP WITH HOOK (K942032) _Hospital For Special Surgery · HRS · Jun 13, 1996 · Orthopedic · SN_ **Canonical URL:** https://fda-staging.innolitics.com/device/K942032 ## Device Facts - **Applicant:** Hospital For Special Surgery - **Product Code:** [HRS](/productcode/HRS.md) - **Decision Date:** Jun 13, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The device is intended to fix periprosthetic fractures of the proximal femur and the humerus in a stable position to allow healing. The plamp plate with trochanteric hook is intended to fix non-unions of the trochanter in a stable position to allow healing. ## Device Story Mechanical bone fixation system; combines bone plate and bone clamps. Clamps attach to plate via screws; bone held between plate and clamps. Components feature small spikes for bone engagement. Periprosthetic fracture fixation supplemented by cortical bone screws passing through plate. Used by orthopedic surgeons in clinical settings to stabilize fractures/non-unions; promotes healing via mechanical stabilization. ## Clinical Evidence Animal model study comparing torsional strength and energy to failure; compared clamp-like device against standard bone plates and intramedullary rods. Results indicated superior in vivo performance of clamp portion regarding torsional strength at failure. ## Technological Characteristics Mechanical bone plate and clamp system; features integrated spikes for bone fixation. Utilizes cortical bone screws for supplemental fixation. No software or electronic components. ## Regulatory 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 - Dall-Miles Trochanteric Cable Grip System (Howmedica) - Dall-Miles Broad Bone Plate (Howmedica) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510(k) SUMMARY HSS PLAMP #K942032 (prepared 4/5/96) JUN 13 1996 Submitter: Bruce H. Robie, Ph.D. Assistant Scientist Department of Biomechanics & Biomaterials Hospital for Special Surgery 535 East 70 Street New York, NY 10021 212.606.1067 (phone) 212.794.4020 (fax) Trade Name(s): Plamp, plamp plate, plamp with hook Common Name: Bone plate with clamps Classification Name: Plate, Fixation, Bone (per 21 CFR 888.3030) The device is intended to fix periprosthetic fractures of the proximal femur and the humerus in a stable position to allow healing. The plamp plate with trochanteric hook is intended to fix non-unions of the trochanter in a stable position to allow healing. The plamp is a mechanical combination of a bone plate and a bone clamp. The clamps connect to the plate via the screws and the bone is held between the plate and the clamps. Both the plate and the clamps have small spikes to fix the components to the bone. For periprosthetic fractures, additional fixation is achieved through the use of cortical bone screws that pass through the plamp plate. It is substantially equivalent to components of the Dall-Miles Trochanteric Cable Grip System (Howmedica) and the Dall-Miles Broad Bone Plate (Howmedica). The use of spikes and clamps to hold fractured bones was examined in an animal model comparing the strength of bones fixed using standard bone plates, intramedullary rods and a clamp-like device. This experiment showed that the *in vivo* performance of the clamp portion of the plamp was superior to the use of plates alone as measured by torsional strength at failure and energy to failure. --- **Source:** [https://fda-staging.innolitics.com/device/K942032](https://fda-staging.innolitics.com/device/K942032) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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