(106 days)
Not Found
No
The device description focuses on mechanical surgical instruments and implants, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device described consists of instruments used for hip surgery, specifically for the implantation of hip stems. These instruments are tools used during a surgical procedure, not the therapeutic device (the hip implant) itself. Their purpose is to facilitate the surgical process.
No
The description focuses on surgical instruments designed for use in total hip arthroplasty, which are tools used during a medical procedure, not for diagnosing conditions.
No
The device description explicitly details physical surgical instruments made of stainless steel, such as broaches, chisels, inserters, and rasps, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes surgical instruments used during a total hip arthroplasty procedure. These instruments are used to prepare the bone and insert the implant. They do not perform tests on bodily samples.
- Intended Use: The intended use clearly states the instruments are for use with hip implant stems in total hip arthroplasty for conditions affecting the hip joint. This is a surgical procedure, not a diagnostic test.
The device described is a set of surgical instruments, which are a different category of medical device than IVDs.
N/A
Intended Use / Indications for Use
The Wright Total Hip Implant Stems for use with these instruments are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed
Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty.
- revision procedures where other treatments or devices have failed
Product codes
KWA, JDI, JDL, LWJ, LZO
Device Description
The design features of the Anterior Approach Hip Surgery Instruments are summarized below:
- Manufactured from Stainless Steel .
- Modular PROFEMUR® Starter Broach provides means to begin preparation of . proximal femur; overall size envelope is smaller than any existing PROFEMUR® stem, allowing usage with all designs; curvature of lateral surface allows insertion without interfering with greater trochanter; engagement with broach handle allows usage in familiar orientation
- Modular PROFEMUR® Box Chisel provides means to remove bone in calcar region, . creating opening for other instruments; curvature of lateral surface allows insertion without interfering with greater trochanter; engagement with broach handle allows usage in familiar orientation
- Modular PROFEMUR® Dimple Stem Inserter provides means by which implant may . be impacted via engagement of dimple on lateral shoulder; engagement with broach handle allows usage in familiar orientation
- Modular PROFEMUR® Pocket Stem Inserter provides means by which implant may . be impacted via engagement of modular neck pocket; engagement with broach handle allows usage in familiar orientation
- Lateralizing Rasp provides rigid, aggressively-toothed surface at end of handle that . can be used to contour the proximal region of the femoral canal.
- Dual-Offset Broach Handles Right and Left broach handles provide improved access . to the proximal femur
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur, femoral canal
Indicated Patient Age Range
skeletally mature patients
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)
Nonclinical Testing: Prototypes were used and further evaluated by the design surgeons in a surgical setting.
Clinical Testing: Clinical data was not provided for the Class I instruments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PROFEMUR® LX 5/8 Hip Stem (K081090), PROFEMUR® TL Hip Stem (K060358)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K102565 (pg 1/2)
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
DEC 2 2 2010
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the Anterior Approach Hip Surgery Instruments.
| (a)(1) Submitted By
Submitter's Name: | Wright Medical Technology, Inc.
5677 Airline Rd. Arlington, TN 38002
800-238-7188 (phone), 901-867-4190 (fax) |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Date:
Contact Person: | December 20, 2010
Gregory Neal
Regulatory Affairs Specialist II |
| (a)(2) Device Name
Proprietary Name:
Common Name: | Anterior Approach Hip Surgery Instruments
Broach, Inserter/Impactor, Chisel, Rasp |
| Classification Name and Reference: | 21 CFR 888.3330 Hip joint metal/ metal
semi-constrained, with an uncemented
acetabular component prosthesis - Class III |
| Subject Device Product Code and Panel Code: | Orthopedics/87/KWA, JDI, JDL, LWJ, LZO |
| (a)(3) Predicate Device
Predicate Proprietary Name: | PROFEMUR® LX 5/8 Hip Stem (K081090)
PROFEMUR® TL Hip Stem (K060358) |
| Predicate Classification and Number: | Orthopedics/87/ KWA, 888.3330 |
(a)(4) Device Description
The design features of the Anterior Approach Hip Surgery Instruments are summarized below:
- Manufactured from Stainless Steel .
- Modular PROFEMUR® Starter Broach provides means to begin preparation of . proximal femur; overall size envelope is smaller than any existing PROFEMUR® stem, allowing usage with all designs; curvature of lateral surface allows insertion without interfering with greater trochanter; engagement with broach handle allows usage in familiar orientation
- Modular PROFEMUR® Box Chisel provides means to remove bone in calcar region, . creating opening for other instruments; curvature of lateral surface allows insertion without interfering with greater trochanter; engagement with broach handle allows usage in familiar orientation
1
- Modular PROFEMUR® Dimple Stem Inserter provides means by which implant may . be impacted via engagement of dimple on lateral shoulder; engagement with broach handle allows usage in familiar orientation
- Modular PROFEMUR® Pocket Stem Inserter provides means by which implant may . be impacted via engagement of modular neck pocket; engagement with broach handle allows usage in familiar orientation
- Lateralizing Rasp provides rigid, aggressively-toothed surface at end of handle that . can be used to contour the proximal region of the femoral canal.
- Dual-Offset Broach Handles Right and Left broach handles provide improved access . to the proximal femur
(a)(5) Intended Use
The Wright Total Hip Implant Stems for use with these instruments are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed
(a)(6) Technological Characteristics of the Device
The indications for implants used with the Anterior Approach Hip Surgery Instruments are identical to instruments used with implants cleared by PROFEMUR® LX 5/8 Hip Stem and PROFEMUR® TL Hip Stem. Materials for the Anterior Approach Hip Surgery Instruments are identical to instruments used with implants cleared by PROFEMUR® TL Hip Stem. The design features of the Anterior Approach Hip Surgery Instruments are substantially equivalent to the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices.
(b)(1) Nonclinical Testing
Prototypes were used and further evaluated by the design surgeons in a surgical setting.
(b)(2) Clinical Testing
Clinical data was not provided for the Class I instruments.
(b)(3) Conclusions
The safety and effectiveness of the Anterior Approach Hip Surgery Instruments are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Mr. Gregory M. Neal Regulatory Affairs Specialist II 5677 Airline Road Arlington, TN 38002
DEC 2 2 2910
K102565 Trade/Device Name: Anterior Approach Hip Surgery Instruments Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, JDI, JDL, LWJ, LZO Dated: November 24, 2010 Received: November 26, 2010
Dear Mr. Neal:
Re:
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
3
Page 2 - Mr. Gregory M. Neal
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
A.S. B. R.
fu
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEC 2 2 2010
Indications for Use
510(k) Number (if known):
Device Name: Anterior Approach Hip Surgery Instruments
Indications For Use:
The Wright Total Hip Implant Stems for use with these instruments are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
-
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
-
- correction of functional deformity; and,
-
- revision procedures where other treatments or devices have failed
Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty. .
Prescription Use X (Part 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)
for M. Melkersm
(Diviston/Sign-Oft) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102565
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