(77 days)
No
The document describes external fixation instrumentation, which are mechanical accessory devices used in surgical procedures. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies. The predicate devices are also traditional mechanical external fixation systems and software for spatial frame planning, not AI/ML-driven systems.
Yes.
The device is intended for use in various medical conditions such as fractures, joint contractures, limb lengthening, and correction of deformities, all of which aim to treat or alleviate a medical condition, qualifying it as a therapeutic device.
No
The device is an external fixation instrumentation used for orthopedic procedures like fracture fixation, limb lengthening, and deformity correction, not for diagnosing medical conditions.
No
The device description explicitly states the devices are "External Fixation Instrumentation" and "accessory devices" used to assist in the implantation of external fixation systems. This indicates physical instruments, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed are all related to the surgical treatment of musculoskeletal conditions (fractures, contractures, deformities, etc.) using external fixation systems. This involves direct intervention on the patient's body.
- Device Description: The device is described as "accessory devices" used to "assist in the implantation of the Smith & Nephew External Fixation Systems." These are instruments used during a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo (within the body) use during surgery.
N/A
Intended Use / Indications for Use
The Smith & Nephew, Inc. External Fixation Instrumentation is intended for use in:
- Post-Traumatic joint contracture which has resulted in loss of range of motion ( not applicable for Smith & Nephew Rail System)
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
- Open and closed fracture fixation
- Pseudoarthrosis of long bones
- Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS Universal Hinge or JET-X Fixator)
- Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
- Correction of segmental bony or soft tissue defects
- Joint arthrodesis (not applicable for Smith & Nephew Rail System)
- Infected fractures or nonunions
- Mini external fixator systems are indicated for the management of comminuted intraarticular fractures of the distal radius (not applicable for Smith & Nephew Rail System)
- Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints. As well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia (not applicable for Smith & Nephew Rail System)
Product codes
KTT, JDW, LXT, OSN
Device Description
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. External Fixation Instrumentation. The subject devices are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew External Fixation Systems and their cleared Indications for Use. Smith & Nephew External Fixation Instruments can be organized into instrument families which are categorized as follows: Tightening/Insertion, Alignment, Guides, and Drills.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Richards External Fixation System (K870961), Richards Titanium Half Pin (K920024), Hex-Field Fixator (K953397), Ilizarov External Fixation System (K962808), Compass Universal Hinge (K970713), Heidelberg External Fixator (K970751), Taylor Spatial Frame External Fixation System (K970748), S&N External Fixation System (K994143), Jet-X TiN Coated Half Pins (K023134), Jet-X HA Coated Half Pins (K023921), External Fixation Systems (K031181), Modification to Jet-X HA Coated Half Pins (K033289), Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR Safe (K042312), Ilizarov Pulley System (K042436), Jet-X Bar System Clamps, Bars, and Posts- MR Safe (K072212), Smith and Nephew Rail System (K090926), Smith and Nephew Circular Fixation System (K093047), Smith and Nephew Spatialframe V4.1 Web-Based Software (K110069)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
K120871('1/2)
Summary of Safety and Effectiveness External Fixation System Instrumentation Smith & Nephew, Inc.
JUN - 7 2012
Date of Summary: March 19, 2012
Gino Rouss Group Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 7135 Goodlett Farms Parkway Memphis, Tennessee 38016 T (901) 399-6707
Contact Person and Address
Name of Device: Smith & Nephew, Inc. External Fixation Instrumentation Common Name: Orthopaedic Surgical Instrumentation Device Classification Name and Reference:
21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories
21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener
Device Class: Class II
Panel Code: Orthopaedics/87
Predicate Devices:
Richards External Fixation System (K870961);
Richards Titanium Half Pin (K920024);
Hex-Field Fixator (K953397);
Ilizarov External Fixation System (K962808);
Compass Universal Hinge (K970713);
Heidelberg External Fixator (K970751)
Taylor Spatial Frame External Fixation System (K970748);
S&N External Fixation System (K994143);
Jet-X TiN Coated Half Pins (K023134);
Jet-X HA Coated Half Pins (K023921);
External Fixation Systems (K031181);
Modification to Jet-X HA Coated Half Pins (K033289);
Jet-X Bar Clamps and Pin Clamps-Non-Magnetic/MR Safe (K042312);
Ilizarov Pulley System (K042436);
Jet-X Bar System Clamps, Bars, and Posts- MR Safe (K072212);
Smith and Nephew Rail System (K090926);
Smith and Nephew Circular Fixation System (K093047);
Smith and Nephew Spatialframe V4.1 Web-Based Software (K110069)
Device Description
Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. External Fixation Instrumentation. The subject devices are accessory devices and are intended to be used to assist in the implantation of the Smith & Nephew External Fixation Systems and their cleared
1
Summary of Safety and Effectiveness External Fixation System Instrumentation Smith & Nephew, Inc.
Indications for Use. Smith & Nephew External Fixation Instruments can be organized into instrument families which are categorized as follows: Tightening/Insertion, Alignment, Guides, and Drills.
Intended Use
External Fixation Systems
-
- Post-Traumatic joint contracture which has resulted in loss of range of motion ( not applicable for Smith & Nephew Rail System)
- Fractures and disease which generally may result in joint contractures or loss of range of 2. motion and fractures requiring distraction
-
- Open and closed fracture fixation
- Pseudoarthrosis of long bones ব .
- Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS 5. Universal Hinge or JET-X Fixator)
-
- Correction of bony or soft tissue deformities (not applicable for COMPASS Universal Hinge)
- Correction of segmental bony or soft tissue defects 7.
- ങ് Joint arthrodesis (not applicable for Smith & Nephew Rail System)
- Infected fractures or nonunions 9.
-
- Mini external fixator systems are indicated for the management of comminuted intraarticular fractures of the distal radius (not applicable for Smith & Nephew Rail System)
-
- Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints. As well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia (not applicable for Smith & Nephew Rail System)
Substantial Equivalence Information
The device specific instruments associated with the implant devices with which they are used are considered substantially equivalent to previously cleared device specific instruments in that both subject and predicate instruments:
- Share the same raw materials; .
- Are manufactured though the same processes; .
- Utilize the same sterilization procedures; and .
- Have similar nature of body contact .
The Smith and Nephew External Fixation Instrumentation are similar in design and function to competing plate and screw surgical instrumentation on the market.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is written in a simple, sans-serif font. The words are arranged horizontally, with 'Public' and 'Health' on the first line and 'Service' on the second line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 7 2012
Smith & Nephew, Incorporated % Mr. Gino Rouss Group Manager, Regulatory Affairs 1450 Brooks Road Memphis, Tennessee 38116
Re: K120871
Trade/Device Name: Smith & Nephew, Incorporated. External Fixation Instrumentation Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliance and accessories
Regulatory Class: Class II Product Code: KTT, JDW, LXT, OSN Dated: March 19, 2012 Received: March 22, 2012
Dear Mr. Rouss:
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.
3
Page 2 - Mr. Rouss
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 forth in the quality systems (OS) 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/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. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Smith & Nephew, Inc. External Fixation Systems Indications for Use:
The Smith & Nephew, Inc. External Fixation Instrumentation is intended for use in:
- Post-Traumatic joint contracture which has resulted in loss of range of motion ( not 1. applicable for Smith & Nephew Rail System)
- Fractures and disease which generally may result in joint contractures or loss of range of 2. motion and fractures requiring distraction
- Open and closed fracture fixation 3.
- Pseudoarthrosis of long bones 4.
- Limb lengthening by epiphyseal or metaphyseal distraction (not applicable for COMPASS 5. Universal Hinge or JET-X Fixator)
- Correction of bony or soft tissue deformities (not applicable for COMPASS Universal 6. Hingel .
- Correction of segmental bony or soft tissue defects 7.
- Joint arthrodesis (not applicable for Smith & Nephew Rail System) 8.
- Infected fractures or nonunions 9.
-
- Mini external fixator systems are indicated for the management of comminuted intraarticular fractures of the distal radius (not applicable for Smith & Nephew Rail System)
-
- Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints. As well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia (not applicable for Smith & Nephew Rail System)
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
(Please do Not Write Below This Line – Continue on Another Page IF Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
Page 1 of 1
510(k) Number K120871