← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K122489 # EMERGE MEDICAL SOLID BONE SCREWS (K122489) _Emerge Medical · HWC · Dec 10, 2012 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K122489 ## Device Facts - **Applicant:** Emerge Medical - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Dec 10, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Emerge Medical Solid Bone Screws are intended to provide bone fixation in the management of osteotomies, fusions, and fractures of metaphysis and diaphysis of both small and large bones and the pelvis. The screws may be used alone or with washers. ## Device Story Emerge Medical Solid Bone Screws consist of cancellous, cortical, and shaft screws, with optional washers, designed for orthopedic bone fixation. Provided non-sterile, these metallic fasteners are used by surgeons to stabilize bone segments during the management of fractures, osteotomies, and fusions in small and large bones and the pelvis. The device functions as a mechanical fixation fastener; it is implanted surgically to provide structural support to bone tissue. Clinical benefit is derived from the stabilization of bone, facilitating healing. ## Clinical Evidence Bench testing only. Static mechanical testing performed per ASTM F543 demonstrated performance equivalent or superior to predicate devices. No clinical data were required to demonstrate substantial equivalence. ## Technological Characteristics Metallic bone fixation fasteners (screws and washers). Materials: Titanium alloy (ASTM F136) and Stainless steel (ASTM F138). Design includes cancellous, cortical, and shaft configurations with varying diameters, lengths, thread patterns (partial/full), and drive types. ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Synthes [K112583](/device/K112583.md) - Synthes [K061621](/device/K061621.md) ## 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}------------------------------------------------ # K122489(1) DEC 1 0 2012 : | 510(k) Summary | | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | NAME OF FIRM: | Emerge Medical
720 S. Colorado Blvd.
Suite 550-S
Denver, CO 80246 | | DATE PREPARED: | November 29, 2012 | | 510(K) CONTACT: | Victoria Trafka
Vice President of Engineering & Quality
Tel: (303) 225-7909 | | PROPOSED TRADE NAME: | Emerge Medical Solid Bone Screws | | DEVICE CLASSIFICATION: | Class II; 21 CFR 888.3040 | | CLASSIFICATION NAME: | Smooth or threaded metallic bone fixation fastener | | PRODUCT CODE: | HWC | | DEVICE DESCRIPTION: | The Emerge Medical Bone Fixation screws consist of cancellous,
cortical and shaft screws with washers, as needed, in a variety of
sizes to accommodate differing anatomic requirements.
The
screws are provided non-sterile. | | INDICATIONS FOR USE: | The Emerge Medical Solid Bone Screws are intended to provide
bone fixation in the management of osteotomies, fusions, and
fractures of metaphysis and diaphysis of both small and large
bones and the pelvis. The screws may be used alone or with
washers. | | MATERIALS: | Titanium alloy (ASTM F136)
Stainless steel (ASTM F138) | | PREDICATE DEVICES: | Synthes K112583 and K061621 | | TECHNOLOGIC
CHARACTERISTICS: | The fundamental scientific principles and technological
characteristics, including the intended use, material, general
design, and sizes of the device are the equivalent the predicate
devices. | | PERFORMANCE DATA: | Static tests performed according to ASTM 543 demonstrated that
the device performs as well as or better than the predicate
devices. Testing included screw variations in material, diameters,
lengths, partial versus full threads, and drive types. Clinical data
were not needed to demonstrate substantial equivalence for these
devices. | - Page 4 of 10- {1}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 · Letter dated: December 10, 2012 Emerge Medical % Ms. Victoria Trafka Vice President of Engineering & Quality 720 South Colorado Boulevard, Suite 550-S Denver, Colorado 80246 Re: K122489 Trade/Device Name: Emerge Medical Solid Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 13, 2012 Received: November 14, 2012 Dear Ms. Trafka: 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 {2}------------------------------------------------ ### Page 2 - Ms. Victoria Trafka 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 Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Statement 510(k) Number (if known): Device Name: Emerge Medical Solid Bone Screws ### Indications for Use: The Emerge Solid Bone Screws are intended to provide bone fixation in the management of rile Emerge Oolle Bone Golows and finetaphysis and diaphysis of both small and large bones and the pelvis. The screws may be used alone or with washers. Over-The-Counter Use __ × Prescription Use OL (21 CFR 807 Subpart C) (21 CFR 801 Subpart D) (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Krishna Asundi for (Division Sign-Off) Division of Orthopedic Devices 2012.12.05 18:11:13 -05'00' --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K122489](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K122489) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com