← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K150693 # PHIN-FX Cannulated Lag Screw System (K150693) _Ascent Medical, LLC · HWC · Oct 13, 2015 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K150693 ## Device Facts - **Applicant:** Ascent Medical, LLC - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Oct 13, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The intended use of the Ascent Medical - PHIN-FX Cannulated Lag Screw System is to draw two or more aligned bone fragments together in an adult patient. The Ascent Medical - PHIN-FX Cannulated Laq Screw System is indicated for use for small and long bone fractures, arthrodesis and osteotomy fixation as follows: The Mini and Small - PHIN-FX Cannulated Lag Screw Systems are indicated for small bone fractures and reduction of the glenoid and humeral head, medial malleolus and fibula, distal tibia and pilon, radius and ulna, olecranon and distal humerus, patella, pelvis, tarsal and fusions, metatarsal and phalangeal and with osteotomies, small bones in the hand and wrist, ligament fixation when appropriate, small joint fusion, and other small bone fragment cancellous fractures and osteotomies where the size of the screw/washer adapts to the specific indication. The Large - PHIN-FX Cannulated Lag Screw System is indicated for long bone fractures and reduction of the intracapsular hip, slipped capital femoral epiphysis with proper image fluoroscopy for proper screw placement, femoral condyles, tibia condyles, ankle arthrodesis, large bone calcaneus and talus, acetabulum, sacroiliac and pelvic disruptions, and other areas where accurate screw/washer placement in long bone is required and adapts to the specific indication. The Ascent Medical - PHIN-FX Cannulated Lag Screw System is not for spinal use. ## Device Story PHIN-FX Cannulated Lag Screw System consists of cannulated bone screws (Mini, Small, Large sets) and matched washers; used for fracture fixation, arthrodesis, and osteotomy. Screws are pre-drilling, self-tapping, and back-tapping; designed for precise placement over guide wires under x-ray/fluoroscopic imaging. Used in clinical settings by surgeons; implants provide mechanical compression to draw bone fragments together. System includes instrumentation for implantation; supplied non-sterile for single-use; requires end-user sterilization. Benefits include stabilization of bone fragments to facilitate healing. ## Clinical Evidence No clinical data. Substantial equivalence is based on engineering and dimensional comparisons to predicate devices. ## Technological Characteristics Cannulated bone screws and washers; materials: 316LVM stainless steel or 6-4 alloyed titanium (color anodized). Features cancellous thread form, pre-drilling, self-tapping, and back-tapping design. Sizes range from 2.0mm to 7.3mm. Non-sterile, single-use, requires end-user sterilization. No software or electronic components. ## 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 - Vilex - Cannulated Bone Screws ([K991197](/device/K991197.md), [K014154](/device/K014154.md)) - Synthes - Cannulated Screws & Washers ([K012945](/device/K012945.md), [K962823](/device/K962823.md), [K963192](/device/K963192.md), [K963172](/device/K963172.md), [K021932](/device/K021932.md), [K962011](/device/K962011.md)) - Zimmer/Pioneer – Cannulated Screw & Washer System ([K102903](/device/K102903.md), [K003496](/device/K003496.md), [K142442](/device/K142442.md)) - Instratek - Mini Cannulated Screws ([K120493](/device/K120493.md)) - Acumed - Cannulated Screw System ([K123890](/device/K123890.md)) - I.T.S. GmbH - Cannulated Screws ([K060156](/device/K060156.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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. The profiles are stylized and appear to be made of flowing lines. October 13, 2015 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Ascent Medical, LLC % Mr. Al Lippincott Engineering Consulting Services, Incorporated 3150 E. 200th Street Prior Lake, Minnesota 55372 Re: K150693 Trade/Device Name: PHIN-FX Cannulated Lag Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: October 1, 2015 Received: October 8, 2015 Dear Mr. Lippincott: 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 {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use #### 510(k) NUMBER: K150693 DEVICE NAME: Ascent Medical - PHIN-FX Cannulated Lag Screw System The intended use of the Ascent Medical - PHIN-FX Cannulated Lag Screw System is to draw two or more aligned bone fragments together in an adult patient. The Ascent Medical - PHIN-FX Cannulated Laq Screw System is indicated for use for small and long bone fractures, arthrodesis and osteotomy fixation as follows: The Mini and Small - PHIN-FX Cannulated Lag Screw Systems are indicated for small bone fractures and reduction of the glenoid and humeral head, medial malleolus and fibula, distal tibia and pilon, radius and ulna, olecranon and distal humerus, patella, pelvis, tarsal and fusions, metatarsal and phalangeal and with osteotomies, small bones in the hand and wrist, ligament fixation when appropriate, small joint fusion, and other small bone fragment cancellous fractures and osteotomies where the size of the screw/washer adapts to the specific indication. The Large - PHIN-FX Cannulated Lag Screw System is indicated for long bone fractures and reduction of the intracapsular hip, slipped capital femoral epiphysis with proper image fluoroscopy for proper screw placement, femoral condyles, tibia condyles, ankle arthrodesis, large bone calcaneus and talus, acetabulum, sacroiliac and pelvic disruptions, and other areas where accurate screw/washer placement in long bone is required and adapts to the specific indication. The Ascent Medical - PHIN-FX Cannulated Lag Screw System is not for spinal use. > Prescription Use XXXXX AND/OR Over-The-Counter-Use __ (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ ### 510(k) Summary of Safety and Effectiveness SAFE MEDICAL DEVICES ACT OF 1990 510(k) Summary | NAME OF FIRM: | Ascent Medical, LLC
Suite 100
4780 I-55 North
Jackson, MS 39211
USA
www.ascentmedical.com | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372
Tel. No. 952-492-5858
e-mail: allippincott@msn.com | | DATE: | July 21, 2015 | | TRADE NAME: | Ascent Medical – PHIN-FX Cannulated Lag Screw System | | COMMON NAME: | Cannulated Bone Screw & Washer System | | DEVICE NAME: | Screw, Fixation, Bone
Washer, Bolt, Nut, Non-Spinal, Metallic | | CLASSIFICATION: | Smooth or Threaded Metallic Bone Fixation Fastener,
Class II (21 CFR, Sec. 888.3040)
Single/multiple component metallic bone fixation appliances and
accessories, Class II (21CRF, Sec. 888.3030) | | DEVICE PRODUCT CODE: | HWC | | SUBSEQUENT
PRODUCT CODE: | HTN | | SUBSTANTIALLY
EQUIVALENT DEVICE | Vilex - Cannulated Bone Screws (K991197, K014154)
Synthes - Cannulated Screws & Washers (K012945, K962823,
K963192, K963172, K021932 & K962011)
Zimmer/Pioneer – Cannulated Screw & Washer System (K102903,
K003496 & K142442)
Instratek - Mini Cannulated Screws (K120493)
Acumed - Cannulated Screw System (K123890)
I.T.S. GmbH - Cannulated Screws (K060156) | {4}------------------------------------------------ #### Ascent Medical - PHIN-FX Cannulated Lag Screw System - K150693 - 510(k) Summary: DEVICE DESCRIPTION: The Ascent Medical – PHIN-FX Cannulated Lag Screw System is a complement of various cannulated bone screws consisting of a 1). Mini Set of 2.0mm, 2.5mm, 3.0mm; 2). Small Set of 3.5mm, 4.0mm, 5.0mm; and 3). Large Set of 6.5mm and 7.3mm sizes with a Short or Long Thread length in numerous screw lengths to be used by the surgeon for various indications in the fracture fixation of small and long bone(s) in the human anatomy. All screws feature a cancellous thread form and are pre-drilling, self-tapping, and back-tapping (if removal is necessary) in design. All screws are used in conjunction with a appropriate sized Guide Wire and x-ray imaging for precise placement in bone across the fracture/osteotomy site. Associated matched size Washers for each screw size system are available for thin cortex or osteopenic bone where the screw head may break through. All Ascent Medical – PHIN-FX System cannulated bone screws & washers are manufactured from either high strength 316LVM Stainless Steel or 6-4 Alloyed Titanium materials. The titanium screws and washers are color anodized as a surface treatment for size recognition. A full compliment of instrumentation is available for use with the system. All implants and instrumentation are designated 'Non-sterile' in a tray/case system for 'single use' and sterilization by the end user. - The intended use of the Ascent Medical PHIN-FX Cannulated Lag INTENDED USE: Screw System is to draw two or more aligned bone fragments together in an adult patient. The Ascent Medical – PHIN-FX Cannulated Lag Screw System is indicated for use for small and long bone fractures, arthrodesis and osteotomy fixation as follows: The Mini and Small - PHIN-FX Cannulated Lag Screw Systems are indicated for small bone fractures and reduction of the glenoid and humeral head, medial malleolus and fibula, distal tibia and pilon, radius and ulna. olecranon and distal humerus, patella, pelvis, tarsal and fusions, metatarsal and phalangeal and with osteotomies, small bones in the hand and wrist, ligament fixation when appropriate, small joint fusion, and other small bone fragment cancellous fractures and osteotomies where the size of the screw/washer adapts to the specific indication. The Large – PHIN-FX Cannulated Lag Screw System is indicated for long bone fractures and reduction of the intracapsular hip, slipped capital femoral epiphysis with proper image fluoroscopy for proper screw placement, femoral condyles, tibia condyles, ankle arthrodesis, large bone calcaneus and talus, acetabulum, sacroiliac and pelvic disruptions, and other areas where accurate screw/washer placement in long bone is required and adapts to the specific indication. The Ascent Medical - PHIN-FX Cannulated Lag Screw System is not for spinal use. {5}------------------------------------------------ | EQUIVALENCE: | The Ascent Medical - PHIN-FX Cannulated Lag Screw System is
Substantially Equivalent(SE) to the predicate systems (as listed). No
nonclinical testing was used in the determination of substantial
equivalence. | |--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SUMMARY OF TECH-
NOLOGICAL
CHARACTERISTICS | The Ascent Medical – PHIN-FX Cannulated Lag Screw System is
Similar in Material, Design, and Indications to the listed predicate.
devices. | | CONCLUSION: | The Ascent Medical – PHIN-FX Cannulated Lag Screw System has
similar indications for use, materials, dimensions, and designs when
compared to the predicate devices. An engineering/dimensional
comparison to the predicate devices was performed to demonstrate
Substantial Equivalence (SE). Based on these similarities, the Ascent
Medical – PHIN-FX Cannulated Lag Screw System is substantially
equivalent to the predicates identified in the 510(k) Summary. | --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K150693](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K150693) **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