(292 days)
K9829953
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an orthopedic implant designed to treat various conditions like degenerative joint disease, rheumatoid arthritis, fractures, and for revision of failed total hip arthroplasty, all of which aim to restore or improve physiological function.
No
The Arcos™ Interlocking Distal Stem is an implantable device designed for use in hip arthroplasty and revision surgery, not for diagnosing medical conditions. It is a therapy device.
No
The device description clearly indicates it is a physical implant (stems, proximal bodies, screws) made from materials like Ti-6Al-4V, intended for surgical implantation in the femoral hip. It is 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 indications clearly describe the device as an implant for treating various conditions of the femoral hip, such as osteoarthritis, rheumatoid arthritis, fractures, and revision of failed hip arthroplasty. These are all clinical conditions treated directly within the body.
- Device Description: The description details a modular femoral revision system with stems and proximal bodies made from materials like Ti-6Al-4V, designed for uncemented applications. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. The device is a physical implant.
Therefore, the Arcos™ Interlocking Distal Stem is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications for the Arcos™ Interlocking Distal Stem include:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
The Arcos™ Interlocking Distal Stems are single-use implants, intended for uncemented applications.
Product codes (comma separated list FDA assigned to the subject device)
KWA, LPH, JDL, LZO, KWZ, JDI, KWY, MAY, MEH
Device Description
The Arcos™ Interlocking Distal Stem was designed to be a part of the Arcos™ Modular Femoral Revision System, a modular system using interchangeable stems and proximal bodies commonly seen in femoral revision surgery. The proximal bodies consist of broached, calcar-replacing, and cone-style implants, made from Ti-6Al-4V (ASTM F-136) and featuring a roller hardened taper, is fully porous coated (Ti-6AL-4V, ASTM F-1580) with a fine buffed finish on the bullet-tip. The distal stems will be offered in a range of diameters from 15-26mm and lengths of 200mm, 250mm, and 300mm. The stems are offered in porous cylindrical with proximal taper and splined tapered designs. The stem provides holes for interlocking screws to provide temporary rotational stability. The system also includes auxiliary implants to aid in fixation. The system is intended for uncemented applications
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
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 following testing was performed to determine substantial equivalence:
- The distal pot fatique test was performed to verify stem strength in the smallest distal . implant design in the Arcos™ Femoral Revision System. As required in ISO 7206-8, six stems were shown to have sufficient strength to survive distal pot fatigue testing to 5 million cycles. Since the smallest design in the Arcos™ Interlocking Distal Stems product line is a 15mm bullet-tipped stem, the orevious testing of the worst case adequately confirms the strength of the smallest stem within this product line.
- The Kaessmann Transverse Screws, cleared in K9829953, were tested for use with femoral implants . two separate times. The test performed was a torsional fatigue test to determine the ability of the screws to provide temporary rotational stability, as stated in the package insert.
- The results indicated that the device was functional within its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K9829953
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K100469 (pg 1/2)
MANUFACTURING CORP.
510(k) Summary
DEC -7 2010
Preparation Date: August 26, 2010
Applicant/Sponsor:
Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Establishment Registration Number: 1825034
Contact Person:
Becky Earl Regulatory Specialist
Arcos™ Interlocking Distal Stem
Proprietary Name:
Common Name:
Femoral Hip Revision Stem
Classification Name:
LPH- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358)
KWA-Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) (21 CFR 888.3330)
JDL- Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) (21 CFR 888.3320)
LZO-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cernented or Non-Porous, Uncemented (21 CFR 888.3353)
KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer (21 CFR 888.3310)
JDI-- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350)
KWY—Prosthesis, Hip, Hemi-Femoral, Metal/Polymer, Cemented or Uncemented (21 CFR 888.3390)
MAY-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous Cemented, Osteophilic Finish (21 CFR 888.3353)
MEH-Prosthesis, Hip, Semi-constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate (21 CFR 888.3353)
Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Office: 574.267.6639 Main Fax: 574.267.8137 www.biomel.com
Shipping Address: 56 E. Bell Drive Warsaw, IN 46582
1
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| K042774 | Mallory-Head® Modular Calcar Stems with Interlocking Slots—Biomet |
|---|---|
| --------- | ------------------------------------------------------------------- |
Biomet® Modular Femoral Revision System K090757
Device Description:
The Arcos™ Interlocking Distal Stem was designed to be a part of the Arcos™ Modular Femoral Revision System, a modular system using interchangeable stems and proximal bodies commonly seen in femoral revision surgery. The proximal bodies consist of broached, calcar-replacing, and cone-style implants, made from Ti-6Al-4V (ASTM F-136) and featuring a roller hardened taper, is fully porous coated (Ti-6AL-4V, ASTM F-1580) with a fine buffed finish on the bullet-tip. The distal stems will be offered in a range of diameters from 15-26mm and lengths of 200mm, 250mm, and 300mm. The stems are offered in porous cylindrical with proximal taper and splined tapered designs. The stem provides holes for interlocking screws to provide temporary rotational stability. The system also includes auxiliary implants to aid in fixation. The system is intended for uncemented applications
Intended Use:
Indications for the Arcos™ Interlocking Distal Stem include:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
The Arcos™ Interlocking Distal Stems are single-use implants, intended for uncemented applications.
Summary of Technologies:
The Arcos™ Interlocking Distal Stems have the same technological characteristics as the predicates listed above, including the same roller hardened taper process, as well as the same titanium porous plasma spray (PPS®) outer-surface coating.
Testing:
The following testing was performed to determine substantial equivalence:
- The distal pot fatique test was performed to verify stem strength in the smallest distal . implant design in the Arcos™ Femoral Revision System. As required in ISO 7206-8, six stems were shown to have sufficient strength to survive distal pot fatigue testing to 5 million cycles. Since the smallest design in the Arcos™ Interlocking Distal Stems product line is a 15mm bullet-tipped stem, the orevious testing of the worst case adequately confirms the strength of the smallest stem within this product line.
- The Kaessmann Transverse Screws, cleared in K9829953, were tested for use with femoral implants . two separate times. The test performed was a torsional fatigue test to determine the ability of the screws to provide temporary rotational stability, as stated in the package insert.
- The results indicated that the device was functional within its intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings forming three distinct segments. The eagle faces left, and encircling it is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomed Manufacturing Corp. % Ms. Becky Earl 56 East Bell Drive P.O. Box 587 Warsaw. IN 46581
DEC 7 2010
Re: K100469 Trade/Device Name: Arcos™ Interlocking Distal Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: III Product Code: KWA, LPH, JDL, LZO, KWZ, JDI, KWY, MAY, MEH Dated: August 26, 2010 Received: November 17, 2010
Dear Ms. Earl
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
3
Page 2 - Ms. Becky Earl
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 (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.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/ReportalProblem/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 vours.
A. B. Rte
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);_K100466
Device Name: Arcos™ Interlocking Distal Stems
Indications For Use:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
-
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
The Arcos™ Interlocking Distal Stems are single-use implants, intended for uncemented applications.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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. Mukkerson
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100469
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