(88 days)
No
The 510(k) summary describes a mechanical orthopedic implant (humeral fracture stem) and its intended use and materials. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components. The performance studies are mechanical testing and finite element analysis, typical for orthopedic implants, not AI/ML validation.
Yes
The device is a prosthetic implant for the shoulder joint, used to treat various musculoskeletal conditions, including degenerative joint disease, fractures, and functional deformities, which falls under the category of therapeutic devices.
No
Explanation: The provided text describes a Comprehensive Humeral Fracture Stem, which is an implant used for joint replacement and fracture repair. Its intended use and device description indicate it is a therapeutic device, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions.
No
The device description clearly details a physical implant (humeral fracture stems) made of various materials and with specific physical features for surgical implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a Comprehensive Humeral Fracture Stem, which is an implantable medical device used to treat fractures and other conditions of the proximal humerus (shoulder bone). It is surgically implanted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, laboratory testing, or providing diagnostic information based on in vitro analysis.
Therefore, this device falls under the category of a surgical implant rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Comprehensive Humeral Fracture Stems are indicated for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Revision where other devices or treatments have failed; 4) Correction of functional deformity; 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; and 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
The Interlok® finish Comprehensive Humeral Fracture Stems are intended for cemented use and the MacroBond™ coated Comprehensive Humeral Fracture Stems are intended for press-fit or cemented application.
Product codes
KWT, KWS, MBF, HSD
Device Description
The Comprehensive Humeral Fracture Stems consists of various lengths and can be provided with an Interlok® finish for cement fixation or with a thin layer of plasma spray coating known as MacroBond™ for press-fit. The device is fluted distally which allows for a cement mantle and an increase in anti-rotational stability. The proximal body of the stem incorporates a reverse Morse taper for the Bio-Modular Heads and 4 fins, three of which include suture holes to facilitate multiple attachment sites for the bone. A collar also exists to minimize subsidence.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, proximal humerus
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)
Non-Clinical Testing: Mechanical Testing and a Finite Element Analysis determined that the Comprehensive Humeral Fracture Stems presented no new risks and were, therefore, substantially equivalent to the predicate devices.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K984541, K961571, K961260, K992119
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
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K02 306 3
page 1 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant or Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, IN 46581-0587 |
|-----------------------|-------------------------------------------------------------------|
| Contact Person: | Patricia Sandborn Beres
Telephone: (574) 267-6639 |
Proprietary Name: Comprehensive Humeral Fracture Stems
Common Name: Humeral Stem
Classification:
- Shoulder joint metal/polymer non-constrained cemented prosthesis (888.3650).
- Shoulder joint metal/polymet/metal non-constrained or semi-constrained porous coated uncemented prosthesis (888.3670).
- Shoulder ioint metal/polymer semi-constrained cemented prosthesis (888.3660)
- Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (888.3690)
Device Classification: Class II
Legally Marketed Devices to which Substantial Equivalence is Claimed: DePuy Orthopaedics' Global® Shoulder- 510(k) K984541, Biomet, Inc.'s Bi-Angular Co-Cr Humeral Components- 510(k) K961571, Kirschner Shoulders With Titanium Plasma Spray-510(k) K961260, and Bio-Modular Shoulder System- 510(k) K992119.
Device Description: The Comprehensive Humeral Fracture Stems consists of various lengths and can be provided with an Interlok® finish for cement fixation or with a thin layer of plasma spray coating known as MacroBond™ for press-fit. The device is fluted distally which allows for a cement mantle and an increase in anti-rotational stability. The proximal body of the stem incorporates a reverse Morse taper for the Bio-Modular Heads and 4 fins, three of which include suture holes to facilitate multiple attachment sites for the bone. A collar also exists to minimize subsidence.
1
K023063
page 2 of 2
Indications for Use: The Comprehensive Humeral Fracture Stems are indicated for 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Revision where other devices or treatments have failed; 4) Correction of functional deformity; 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; and 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Summary of Technologies: The Comprehensive Humeral Fracture Stems - the materials, design, sizing, and indications are similar or identical to the predicate devices.
Non-Clinical Testing: Mechanical Testing and a Finite Element Analysis determined that the Comprehensive Humeral Fracture Stems presented no new risks and were, therefore, substantially equivalent to the predicate devices.
Clinical Testing: No clinical testing was provided as a basis for substantial equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD. 20850
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K023063
Trade/Device Name: Comprehensive Humeral Fracture Stems Regulation Numbers: 21 CFR 888.3650; 21 CFR 888.3660; 21 CFR 888.3670; 21 CFR 888.3690 Regulation Names: Shoulder joint metal/polymer non-constrained cemented prosthesis; Shoulder joint metal/polymer semi-constrained cemented prosthesis; Shoulder joint metal/polymer/metal non-constrained or semiconstrained porous-coated uncemented prosthesis; Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: II Product Codes: KWT, KWS, MBF, HSD
Dated: September 12, 2002
Received: September 16, 2002
Dear Ms. Beres:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 mav publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Patricia Sandborn Beres
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); good manufacturing practice requirements as set 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) NUMBER (if KNOWN):
DEVICE NAME: Comprehensive Humeral Fracture Stems
INDICATIONS FOR USE:
The Comprehensive Humeral Fracture Stems are indicated for 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) Rheumatoid arthritis; 3) Revision where other devices or treatments have failed; 4) Correction of functional deformity; 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate; and 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
The Interlok® finish Comprehensive Humeral Fracture Stems are intended for cemented use and the MacroBond™ coated Comprehensive Humeral Fracture Stems are intended for press-fit or cemented application.
for Mark n Millhuser
Division Sign-Division of Gereral, Pestor and Neurological Devices
5100 Part Number K623063
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
0000000