(76 days)
No
The summary describes a mechanical suture anchor and its intended uses, with no mention of AI or ML technology.
Yes
The device is described as a suture anchor intended for the reattachment of soft tissue to bone, which falls under the definition of a therapeutic intervention.
No
The document describes a suture anchor used for reattaching soft tissue to bone, which is a therapeutic device, not a diagnostic one. Its intended use is for surgical repair, not for identifying conditions or diseases.
No
The device description clearly states it is a suture anchor manufactured from PEEK, which is a physical material, and includes an anchor, plug, and inserter, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that the Smith & Nephew FOOTPRINT Ultra PK Suture Anchor is a physical implant used to reattach soft tissue to bone during surgical procedures. It is a medical device used in vivo (within the body), not in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Product codes
MBI
Device Description
The FOOTPRINT Ultra PK is a suture anchor manufactured from PEEK (polyetheretherketone). The tap-in anchor incorporates an anchor and plug and is pre-assembled on an inserter. The anchor accommodates up to four strands of suture and is offered diameters of 4.5 mm and 5.5 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Hand/Wrist, Elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew FOOTPRINT Ultra PK suture and nixe substantially equivalent to the predicate Arthrex PushLock suture anchor, cleared via K051219 . The testing also demonstrates the new device does not raise any new issues of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
KO9389
SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
As required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew FOOTPRINT Ultra PK Suture Anchor
Date Prepared: December 17, 2009
MAR - 4 2010
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810
B. Company Contact
Christina Flores Regulatory Affairs Specialist II (508) 261-3705 Phone: FAX: (508) 261-3620
C. Device Name
Trade Name: FOOTPRINT Ultra PK Suture Anchor Common Name: Suture Anchor Classification Name: Fastener, fixation, non-degradable, soft tissue
D. Predicate Devices
The Smith & Nephew FOOTPRINT Ultra PK suture anchor is substantially equivalent in Intended Use and fundamental scientific technology to the legally marketed Smith & Nephew Twinfix FP PK Suture Anchor cleared via K073509 and the Arthrex PushLock cleared via K051219.
Description of Device E.
The FOOTPRINT Ultra PK is a suture anchor manufactured from PEEK (polyetheretherketone). The tap-in anchor incorporates an anchor and plug and is pre-assembled on an inserter. The anchor accommodates up to four strands of suture and is offered diameters of 4.5 mm and 5.5 mm.
l
1
K199389
F. Intended Use
The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
G. Comparison of Technological Characteristics
The Smith & Nephew FOOTPRINT Ultra PK suture anchor is substantially equivalent in intended use, technological characteristics, and are as safe and effective as their currently marketed predicate devices, the Smith & Nephew Twinfix PK FP (K073509), and the Arthrex PushLock (K051219).
H. Summary Performance Data
The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew FOOTPRINT Ultra PK suture and nixe substantially equivalent to the predicate Arthrex PushLock suture anchor, cleared via K051219 . The testing also demonstrates the new device does not raise any new issues of safety and efficacy.
Traditional 510(k) Section IV
2
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew Inc., Endoscopy Division % Ms. Christina Flores Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810
MAR - 4 2010
Re: K093897
Trade/Device Name: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: December 17, 2009 Received: December 18, 2009
Dear Ms. Flores:
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. Iisting 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
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Page - 2 Ms. Christina Flores
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.fdagov/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.fdagov/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark Milliken
Mark N. Melkerson 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 FOOTPRINT Ultra PK Suture Anchor
Indications for Use:
The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: -
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (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)
Sousta of m xn
(Division Sign Off)
n of Surgical, Orthor and Restorative Devices
510(k) Number K093897