(181 days)
No
The device description and intended use are for a physical implant (acetabular shells and liners) used in hip replacement surgery. There is no mention of software, algorithms, or any computational processing that would involve AI or ML.
Yes
The device is an acetabular shell system for total hip replacement, which is a medical intervention intended to treat and alleviate various musculoskeletal conditions and impairments, such as degenerative joint disease, arthritis, fractures, and deformities, thereby improving patient function and reducing pain.
No
The device is an acetabular shell system for total hip replacement, which is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "metal backed shell with a polyethylene inner liner," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a medical device intended for surgical implantation as part of a total hip replacement. It is a physical component (acetabular shell and liner) used to replace a damaged joint.
- Lack of Specimen Analysis: There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
Therefore, based on the provided information, the Rx90™ Low Profile Acetabular Shells are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Rx90™ Low Profile Acetabular System is indicated for cemented or non-cemented use in cases of:
- Cemented of Your Gementou assive joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Correction of functional deformity
-
- Oorlection of functional goromal neck fracture, and trochanteric fractures of the freatment of nort anion, renom to unmanageable by other techniques.
-
- Revision of previously failed total joint replacement.
Specific indications for compatible components that can be used with the above acetabular shells include:
Salvage/Oncology Hip and Total Femur System (K002757, K021380, K033871)
- Oalvager Onoology Thip divint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis
-
- Correction of varus, valgus or post traumatic deformity
-
- Gorrection of varies, valges of post frame of throdesis, or previous joint replacement
-
- Ligament deficiencies
-
- Tumor resections
-
- Turnol Tesections femur with head involvement, unmanageable using other techniques
-
- Revision of previously failed total joint replacement
-
- Trauma
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal rovision, tradima, nuclement the fixation and stability of a standard type hip replacement prosthesis. (K990830, K042774)
The Freedom™ Constrained Liners are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft Itsk of hip dislocation uto to a motory of proposative instability and for whom all other laxity, neuromusodial diodate, or intra operative into been considered. (K030047)
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, JDI, KWZ, MEH
Device Description
The Rx90™ Low Profile Acetabular System is a metal backed shell with a poyeltryien internation of a total hip replacement. The metallic replacement of the acetabular portion of a total hip replacement. The metallic shell is available in diameters of 40mm to 70mm and two different hole configurations. Liners are available with internal diameters of 22mm, 28mm, 32mm and 36mm. Liner styles include Hi-Wall, 10 Degree, MROM, +5mm Hi10 Degree, and Somm. Flat Face and Constrained.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, acetabular portion
Indicated Patient Age Range
The Freedom™ Constrained Liners are intended for general use in skeletally mature individuals.
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 has demonstrated the ability of the device to perform as expected.
Clinical Testing: None provided
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.
K920639, K926107, K030055, K023357
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.
K002757, K021380, K033871, K990830, K042774, K030047
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
p. 1/3
BIOMET
APR 2 8 2005
510(k) Summary
Applicant/Sponsor:Biomet Manufacturing Corp.
Patricia Sandborn Beres Contact Person: Senior Regulatory Specialist
Proprietary Name: Rx90™ Low Profile Acetabular System
Common Name: Acetabular component of a total hip replacement
Classification Name(s):
- Classification Name(s):
- Hip joint metal/polymer/metal semi-constrained porous-coated uncemented
- Hip joint metal/polyment as as as a prosthesis (21 CFR 888.3358)
- 888.3350)
-
- Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous
- Hip joint metal/ceramic/polymer semi-constract Hip Joint mosthesis (21 CFR 888.3353)
- CFR 888.3310)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed. The Legally Marketed Devices 10 Winter System is substantialy equivalent to Biomet
Rx90™ Low Profile Acetabular System is substantialy equivalent to Biomet
Px90™ Low Profile Acet RX90 ™ Low Profile Acollowing 510(k) submissions:
| K920639 | Rx90™ Acetabular Component System |
|---|---|
| K926107 | ArCom® Acetabular Liners and Components |
| K030055 | Expanded indications for Non-Cemented Porous Coated Total |
| Hip Prostheses | |
| K023357 | ArCom® Polyethylene Liners and Components (1050 Resin) |
Device Description: The Rx90™ Low Profile Acetabular System is a metal Device Description: The K20 " Lew intended for cemented or cementless backed shell with a poyeltryien internation of a total hip replacement. The metallic
replacement of the acetabular portion of a total hip replacement. The metallic replacement of the acetabular portion of a Tomm and two different hole
shell is available in diameters of 40mm to 70mm and two different hole shell is available in diameters of 40mm to 70mm diameters of 22mm, 28mm,
configurations. Liners are available with internal diameters of 22mm H configurations. Liners are available will interner of the more of the Mi32mm and 36mm. Liner styles include Hi-Wall, 10 Degree, MROM, +5mm Hi10 Degree, The T Szhin and Somm. Flat Face and Constrained.
MAILING ADDRESS P.(). Box 587 Warsaw, IN 46581-0587
트
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
19
OFFICE 574.267.6639
I·AX 574.267.8137
E-MAIL biomet@blomet.com
1
042989
p. 2/3
510(k) Summary Rx90™ Low Profile Acetabular System Page 2
Intended Use: The Rx90™ Low Profile Acetabular System is indicated for cemented or non-cemented use in cases of:
- Cemented of Your Gementou assive joint disease including osteoarthritis and avascular necrosis
-
- Rheumatoid arthritis
-
- Correction of functional deformity
-
- Oorlection of functional goromal neck fracture, and trochanteric fractures of the freatment of nort anion, renom to unmanageable by other techniques.
-
- Revision of previously failed total joint replacement.
Specific indications for compatible components that can be used with the above acetabular shells include:
Salvage/Oncology Hip and Total Femur System (K002757, K021380, K033871)
- Oalvager Onoology Thip divint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis
-
- Correction of varus, valgus or post traumatic deformity
-
- Gorrection of varies, valges of post frame of throdesis, or previous joint replacement
-
- Ligament deficiencies
-
- Tumor resections
-
- Turnol Tesections femur with head involvement, unmanageable using other techniques
-
- Revision of previously failed total joint replacement
-
- Trauma
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal rovision, tradima, nuclement the fixation and stability of a standard type hip replacement prosthesis. (K990830, K042774)
The Freedom™ Constrained Liners are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft Itsk of hip dislocation uto to a motory of proposative instability and for whom all other laxity, neuromusodial diodate, or intra operative into been considered. (K030047)
2
042989
$\rho^{3/3}$
510(k) Summary Rx90™ Low Profile Acetabular System Page 3
Summary of Technologies: The technological characteristics (materials, design, Summary of Treennologies: The Rx90™ Low Profile Acetabular System are similar to or identical to the predicate devices
Non-Clinical Testing: Mechanical testing has demonstrated the ability of the device to perform as expected.
Clinical Testing: None provided
All trademarks are property of Biomet, Inc.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wavy lines emanating from the head or top portion of the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2005
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K042989
R042987
Trade/Device Name: Rx90™ Low Profile Acetabular System Trade/Device Name: Tel. 76.70
Regulation Number: 21 CFR 888.3358, 888.3353, 888.3350, 888.3310 Regulation Number: 21 CFK 886.5536, 000.5993, 00015-004ted uncemented or Hip Joint inctal polymer semi-constrained smi-constrained cemented or prosulesis, THP Joint metal certains: [Hip joint metal/polymer semi-constrained non-porous uncemented prosit metal/polymer constrained cemented or uncemented prosthesis
Regulatory Class: II Regulations Code: LPH, LZO, JDI, KWZ, MEH Dated: January 26, 2005 Received: January 28, 2005
Dear Ms. Beres:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) prematics is substantially equivalent (for the indications
referenced above and have determined the device merketed in interstate referenced above and nave determined the devices marketed in interstate for use stated in the enclosure) to regally manced promotical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chartere with the provisions of the Federal Food, Drug, devices that have been recults approval of a proval et a provision (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do hot require approvate controls provisions of the Act. The You may, therefore, market the device, subject to use going misbranding and general controls provisions of the Fectinerals requires against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. Times 800 - 800 - 800 - 800 - 8 may be subject to such additional controlist Entrological of 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to Register be found in the Code of Pederal Regarning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substance on the requirements of the Act
that FDA has made a determination that your device are and areasing. You must that FDA has made a delermination that your and regulation to registration and list or any Federal statures and regulations daministered by end to: registration and listing (21
4
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
s the electronic and started on GED Rate 820); and if applicable, the electronic CFR Part 807); labeling (21 CFR Patl of ); good manatoaning platfornicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and if applicable, 1 forth in the quality systems (QS) regulation (2) -51 -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action 5 product radiation control provisions (Scellons 35 - 3 12 6 cccribed in your Section 510(k)
This letter will allow you to begin marketing your device to a legal This letter will allow you to begin marketing your actives of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence than premarket notification. The FDA inding of substantial equive 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
rs of the many of the many of an 076, 0100 - Alex mass note the regulation If you desire specific advice for your acvice on our acoming the regulation entitled, the regulation entitled, the regulation contact the Office of Complance at (240) 270 - 1707 Pat 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CTR Pat 807.97). "Misbranding by reference to prematics notification" (1) & Act from the Division of Small other general information on your responsionities and its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistanto a reservedraindustry/support/index.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/suppo
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K042989
Device Name: _Rx90™ Low Profile Acetabular System
Indications For Use:
Rx90™ Low Profile Acetabular Shells are intended for cemented or non-cemented total hip replacement in cases of
-
- Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- ર્ભ 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.
- ഗ് Revision of previously falled total hip arthroplasty.
Specific indications for compatible components that can be used with the above acetabular shells include:
Salvage/Oncology Hip and Total Femur System (K002757, K021380, K033871)
-
- Palnful and disabled joint resulting from avescular necrosis, osteoarthritis, traumatoid arthrills, traumatic arthrills, traumatic arthritis
-
- Correction of varus, valgus or post traumatic deformity
-
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
-
- Ligament deficiencies
-
- Tumor resections
-
- Treatment of non-unions, femoral neck and trochanteric fracture of the proximal femur with head involvement, unmanageable using other techniques
-
- Revision of previously failed total joint replacement
-
- Trauma
Interiocking hip stems are Indicated for non-comented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bace loss may compromise the fixation and stability of a standard type hip replacement prosthesis. (K990830, K042774)
The Freedom™ Constrained Liners are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high dislocation due to a history of prior dislocation, joint or bone loss, soft laxlty, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. (030047)
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)
Restorative
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