(185 days)
No
The document describes a passive implant (acetabular shell) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The Porous Titanium Acetabular Shells are medical implants used in total hip replacement surgeries to correct functional deformity, treat non-union or fractures, and revise failed hip arthroplasties; these applications directly address and alleviate medical conditions or injuries.
No
This device is an implantable acetabular shell used in total hip replacement surgery, falling under the category of a therapeutic device rather than a diagnostic one.
No
The device description clearly states it is a physical implant made of porous titanium alloy, intended for surgical use in hip replacement. It is a hardware device.
Based on the provided text, 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 for diagnosis, monitoring, or screening.
- Device Description: The description clearly states the device is a "Porous Titanium Acetabular Shell" intended for "reconstruction of the hip joint due to disease, deformity, or trauma." It is a physical implant used within the body.
- Intended Use/Indications for Use: The indications describe conditions requiring hip replacement surgery, which is a surgical procedure involving the implantation of a device, not the analysis of bodily specimens.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic testing, or laboratory procedures typically associated with IVDs.
Therefore, the Porous Titanium Acetabular Shell is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Porous Titanium Acetabular Shells are indicated for cemented or non-cemented use in total hip replacement in cases of:
- 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.
Specific indications for compatible components (femorals, heads, liners, and screws) that can be used with the Regenerex™ Hip Products include:
Freedom® Constrained Liners (K030047)
The Biomet Freedom® Constrained liner is indicated for use as a component of a total hip prosthesis in primary and/or revision patients at hip dislocation due to history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Tri-Polar System (K991990)
Indication #5 (Revision of previously failed total hip arthroplasty) is further specified to include recurrent dislocation.
OSS/Salvage Systems/Total Femur (K974558, K002757, K021380, K033871)
Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrodesis.
Interlocking Stems (K990830, K042774)
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
HA PMI Hip Femoral Stems (K030048)
Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.
Gross Hip Femoral (K001580) and Bohn Hip Femoral (K000262)
These femoral components are also indicated for treatment in conjunction with tumor resection and trauma.
Taper 2 ™ Porous Femoral (K050441) and Balance Microplasty (K050251)
Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. These stems are indicated for the revision of previously failed femoral head resurfacing component.
Color Buffed Femoral (K992903), CB DDH Femoral (K012019), Bi-Metric Hip (K992058), CB Answer Femoral (K991987), Reach Femoral (K982367)
Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. The statement should read, "Revisions of hip replacement components".
150mm Bi-Metric Hip Stem (K983710)
Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. They are not indicated for revision procedures.
Zirconia Ceramic Heads (K964431 and K991708)
Indication #4 (Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques) is not applicable to these Zirconia Ceramic Heads.
Biolox® delta Ceramic Heads (K042091), Rx90™ Standard/Lateralized Femoral (K023085), Portrait Femoral (K010560), Mallory/Head Smooth Femoral (K994007), Generation 4 Polished Femoral (K031734), Modular Reach Femoral (K994038),
Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. The statement should read, "Revision procedures where other treatment or devices have failed".
Medallion Modular Hip System (K041850)
Same list of five indications but cleared for uncemented use only.
Product codes
LPH, LZO, JDI, KWZ, MEH, MAY
Device Description
Porous Titanium Acetabular Shells are Intended for use in reconstruction of the hip joint due to disease, deformly, or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant.
This submission includes acetabular shells for use as reconstructive components. The acetabular shells range In size (OD) from 52mm to 80mm in 2mm Increments. The shell is constructed of a porous titanlum allov (Ti-6Al-4V) and has been designed for cemented or non-cemented use with the option of using screws for added fixation to the native bone. The wall of the shell is composed entirely of the porous material. The rim of the implant is solld titanlum for reinforcement and provides the mating geometry necessary to mate with the instrumentation. The acetabular shells are designed for use with commercially available all polyethylene acetabular liners. These polyethylene ilners are to be cemented into the acetabular shells.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip joint
Indicated Patient Age Range
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: Non-cilnical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its Intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K030047, K991990, K974558, K002757, K021380, K033871, K990830, K042774, K030048, K001580, K000262, K050441, K050251, K992903, K012019, K992058, K991987, K982367, K983710, K964431, K991708, K042091, K023085, K010560, K994007, K031734, K994038, K041850
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the word BIOMET in a bold, sans-serif font. The letters are white with a thick black outline. The letters are all capitalized and evenly spaced. The overall impression is one of strength and stability.
178 - J
510(k) Summary
Preparation Date: April 26, 2006
Applicant/Sponsor: Blomet Manufacturing Corp.
Contact Person: Tracy Bickel Johnson, RAC
Proprietary Name: Porous Titanium Acetabular Shells
Common Name: Acetabular shells
Classification Name: Hip joint, Metal, semi-constrained, porous-coated uncemented prosthesis (888.3358); Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented (888.3350); Hip foint metal/polymer constrained cemented or uncemented prosthesis (888.3310); Hip foint metal/ceramic/polymer semi-constrained cemented or non porous uncemented prosthesis (888.3353)
Legally Marketed Devices To Which Substantlal Equivalence Is Claimed: Hedrocel® Revision Shells (K001759), Hedrocel® Acetabular Cages (K983837)
Device Description: Porous Titanium Acetabular Shells are Intended for use in reconstruction of the hip joint due to disease, deformly, or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant.
This submission includes acetabular shells for use as reconstructive components. The acetabular shells range In size (OD) from 52mm to 80mm in 2mm Increments. The shell is constructed of a porous titanlum allov (Ti-6Al-4V) and has been designed for cemented or non-cemented use with the option of using screws for added fixation to the native bone. The wall of the shell is composed entirely of the porous material. The rim of the implant is solld titanlum for reinforcement and provides the mating geometry necessary to mate with the instrumentation. The acetabular shells are designed for use with commercially available all polyethylene acetabular liners. These polyethylene ilners are to be cemented into the acetabular shells.
Intended Use:
Please note that the indications for the compatible product listing have not been changed and/or modified for this submission.
The Porous Titanium Acetabular Shells are indicated for cemented use in total hip replacement in cases of:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Correction of functional deformity.
- বে Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- ร์.
บก Revision of previously failed total hip arthroplasty.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
.
SHIPPING ADDRESS 56 11. Bell Drive Warsaw. IN 46582
.
OPPICE 574.267.6639
ドヘズ 574.267.8157
N 46552
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E-MAIL blomet@blomet.com
1
Page 2 of 3 510(k) Summary - Porous Titanium Acetabular Shells Blomet Manufacturing Corp.
Specific Indications for compatible components (femorals, heads, liners, and screws) that can be used with the Regenerex™ Hip Products include:
Kor7996
Ereedom® Constrained Liners (K030047)
The Blomet Freedom® Constrained liner is indicated for use as a component of a total hip prosthesis in primary and/or revision patients at high risk of history of prior dislocation, bone loss. joint or soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Tri-Polar System (K991990)
Indication #5 (Revision of previously failed total hip arthroplasty) is further specified to include recurrent distocation.
OSS/Salvage Systems/Total Femur (K974558, K002757, K021380, K033871) Salvage/Oncology Hip and Total Femur components are also indicated for cases of Ilgament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrodesis.
Interiocking Stems (K990830. K042774)
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
HA PMI Hip Femoral Stems (K030048)
Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-Inflammatory degenerative folnt disease.
Gross Hip Femoral (K001580) and Bohn Hip Femoral (K000262)
These femoral components are also indicated for treatment in confunction with tumor resection and trauma.
Taper 2™ Porous Femoral (K050441) and Balance Microplasty (K050251)
Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. These stems are indicated for the revision of previously failed femoral head resurfacing component.
Color Buffed Femoral (K992903). CB DDH Femoral (K012019), Bi-Metric Hip (K992058), CB Answer Femoral (K991987), Reach Femoral (K982367),
Indication #5 (Revision of previously failed total hip arthroplasty) instead reads. "Revisions of hip replacement components".
150mm Bi-Metric Hip Stem (K983710)
Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. They are not Indicated for revision procedures.
Zirconia Ceramic Heads (K964431 and K991708)
Indication #4 (Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques) Is not applicable to these Zirconia Ceramic Heads,
2
Page 3 of 3 510(k) Summary - Porous Titanium Acetabular Shells Blomet Manufacturing Corp.
Biolox® detta Ceramic Heads (K042091), Rx90™ Standard/Lateralized Femoral (K023085), Portrait Femoral (K010560), Mallory/Head Smooth Femoral (K994007), Generation 4 Pollshed Femoral (K031734), Modular Reach Femoral (K994038),
Kos 2996
Indication #5 (Revision of previously failed total hip arthroplasty) Instead reads, "Revision procedures where other treatment or devices have failed".
Medallion Modular Hip System (K041850) Same list of five indications but cleared for uncemented use only.
Summary of Technologies: The technological characteristics (material modification, design, sizing, Indications) of the Porous Titanium Acetabular Shells are similar to or identical to the predicate devices.
Non-Clinical Testing: Non-cilnical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its Intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Blomet, Inc. except for Hedrocel®, which is property of Zimmer Holdings
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 7 2 2006
Biomet Manufacturing Corp. c/o Ms. Tracy Bickel Johnson, RAC Manager, Regulatory Affairs P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K052996
Trade/Device Name: Porous Titanium Acetabular Shells Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, JDI, KWZ, MEH, MAY Dated: April 17, 2006 Received: April 18, 2006
Dear Ms. Johnson:
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.
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 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); 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.
4
Page 2 - Ms. Tracy Bickel Johnson, RAC
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Neilkr Ogden
Mark N. Melkerson 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): K052996
Device Name: Porous Titanium Acetabular Shells
Indications for Use:
The Porous Titanium Acetabular Shells are indicated for cemented or non-cemented use in total hip replacement in cases of:
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
- Correction of functional deformity. 3.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal ধ femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
Specific indications for compatible components (femorals, heads, liners, and screws) that can be used with the Regenerex™ Hip Products include:
Freedom® Constrained Liners (K030047)
The Biomet Freedom® Constrained liner is indicated for use as a component of a total hip prosthesis in primary and/or revision patients at hip dislocation due to history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Tri-Polar System (K991990)
Indication #5 (Revision of previously failed total hip arthroplasty) is further specified to include recurrent dislocation.
OSS/Salvage Systems/Total Femur (K974558. K002757, K021380, K033871)
Salvage/Oncology Hip and Total Femur components are also indicated for cases of figament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrodesis.
Interlocking Stems (K990830, K042774)
Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
Prescription Use × (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)
Nigh for mem
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 2
Kc52996
6
Porous Titanium Acetabular Shells K052996 Indications for Use
HA PMI Hip Femoral Stems (K030048)
Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.
Gross Hip Femoral (K001580) and Bohn Hip Femoral (K000262)
These femoral components are also indicated for treatment in conjunction with tumor resection and trauma.
Taper 2 ™ Porous Femoral (K050441) and Balance Microplasty (K050251) Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. These stems are indicated for the revision of previously failed femoral head resurfacing component.
Color Buffed Femoral (K992903), CB DDH Femoral (K012019), Bi-Metric Hip (K992058), CB Answer Femoral (K991987), Reach Femoral (K982367)
Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. The statement should read, "Revisions of hip replacement components".
150mm Bi-Metric Hip Stem (K983710)
Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. They are not indicated for revision procedures.
Zirconia Ceramic Heads (K964431 and K991708)
Indication #4 (Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques) is not applicable to these Zirconia Ceramic Heads.
Biolox® delta Ceramic Heads (K042091), Rx90™ Standard/Lateralized Femoral (K023085), Portrait Femoral (K010560), MalloryHead Smooth Femoral (K994007), Generation 4 Polished Femoral (K031734), Modular Reach Femoral (K994038),
Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. The statement should read, "Revision procedures where other treatment or devices have failed".
Medallion Modular Hip System (K041850) Same list of five indications but cleared for uncemented use only.
Mikre R. John faimitin
and Neurological Devices
510(k) Number_ K- C52 99 k