Bone Screws 6.5mm
Device Facts
| Record ID | K172456 |
|---|---|
| Device Name | Bone Screws 6.5mm |
| Applicant | Lima Corporate S.P.A. |
| Product Code | LPH · Orthopedic |
| Decision Date | Jan 4, 2018 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 888.3358 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; inflammatory degenerative joint disease such as rheumatoid arthritis; treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods; revision of a failed primary implant; cuff tear arthropathy (CTA Heads only); glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR Hybrid Glenoid only). The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Hybrid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed. The Delta TT Acetabular System is 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 and hip dysplasia; Rheumatoid arthritis; Post-traumatic arthritis; Correction of functional deformity; Fractures, dislocation of the hip and unsuccessful cup arthroplasty. Revisions in cases of good remaining bone stock.
Device Story
Bone screws (6.5mm diameter) provide supplemental fixation for Delta TT acetabular cups and SMR Shoulder System metal-back glenoids. Screws are implanted by orthopedic surgeons during hip or shoulder arthroplasty procedures. Input is the surgical site; output is mechanical stability of the prosthetic components to the bone. Screws are manufactured from Ti6Al4V. Device benefits include enhanced component fixation, reducing risk of loosening or migration. No software or algorithms involved.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via non-clinical assessment of design, material, and manufacturing consistency with predicate devices. LAL testing performed to ensure compliance with pyrogen limit specifications (20EU/device).
Technological Characteristics
Material: Ti6Al4V (ISO 5832-3, ASTM F1472). Form factor: 6.5mm diameter bone screws in various lengths. Function: Mechanical fixation for orthopedic implants. Sterilization: Not specified, but consistent with predicate. No software or electronic components.
Indications for Use
Indicated for skeletally mature patients requiring total hip arthroplasty (Delta TT) or partial/total/revision shoulder joint replacement (SMR). Shoulder indications include degenerative joint disease (osteoarthritis, avascular necrosis, rheumatoid arthritis), acute humeral head fractures, failed primary implants, cuff tear arthropathy, and glenoid arthrosis. Reverse shoulder requires grossly rotator cuff deficient joint, severe arthropathy, and functional deltoid muscle. Hip indications include osteoarthritis, avascular necrosis, hip dysplasia, rheumatoid arthritis, post-traumatic arthritis, functional deformity, fractures, dislocation, and revision with good bone stock.
Regulatory Classification
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.
Predicate Devices
- Delta TT Acetabular System (K112898, K141395)
- SMR Shoulder System (K110598, K113254, K133349, K161120, K163397)
- Continuum Acetabular System (K091508)
- Comprehensive Reverse Shoulder System (K080642, K113121)
- Aequalis PerFORM Reversed (K161742)
- ReUnion RSA Shoulder System (K161863)
Submission Summary (Full Text)
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January 4, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
LimaCorporate S.p.A. Stephen J. Peoples Principal Consultant Via Nazionale, 52 33038 Villanova di San Daniele del Friuli Udine, Italy
Re: K172456
Trade/Device Name: Bone Screws 6.5mm 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, MBL, PHX, LZO, MBF Dated: December 1, 2017 Received: December 5, 2017
Dear Stephen Peoples:
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. 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 of medical device-related adverse events) (21 CFR 803); good
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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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### Indications for Use Statement
510(k) Number (if known): _K172456
# SMR Shoulder System Indications for Use
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:
- non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; ●
- inflammatory degenerative joint disease such as rheumatoid arthritis; ●
- treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods; ●
- revision of a failed primary implant;
- cuff tear arthropathy (CTA Heads only);
- glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification ● (SMR Hybrid Glenoid only).
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Hybrid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
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| System | | | | Use | |
|--------|----|----------------------------------------------------|-------------------|-----|---------|
| A | R | Components | Material | Cem | Not Cem |
| • | • | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | |
| • | • | SMR Stems (Cementless Finned, Cementless Revision) | Ti6Al4V | | X |
| • | | SMR Humeral Bodies (Trauma, Finned) | Ti6Al4V | X | X |
| • | • | SMR Reverse Humeral Body | Ti6Al4V | X | X |
| • | • | Humeral Extension | Ti6Al4V | X | X |
| • | • | SMR Humeral Heads (Standard, CTA) | CoCrMo | X | X |
| • | | SMR Adaptor Tapers (Neutral, Eccentric) | Ti6Al4V | X | X |
| • | | SMR CTA Head Adaptor for Reverse Humeral Body | Ti6Al4V | X | X |
| | • | SMR Glenospheres | CoCrMo | | X |
| | • | SMR Connectors | Ti6Al4V | | X |
| | • | Reverse Liners | UHMWPE | X | X |
| • | | SMR Cemented Glenoids | UHMWPE | X | |
| • | | SMR 3 Pegs Cemented Glenoids | UHMWPE | X | |
| • | •* | SMR Hybrid Glenoid | UHMWPE+Ti6Al4V+Ta | X | X |
| | • | SMR Hybrid Reverse Baseplate + Screw | Ti6Al4V | | X |
| • | • | SMR Metal Back Glenoids | Ti6Al4V+PoroTi | X* | X* |
| • | • | SMR TT Metal Back Baseplate | Ti6Al4V | X* | X* |
| • | • | SMR TT Metal Back Peg | Ti6Al4V | X* | X* |
| • | | SMR Metal Back Liner | UHMWPE | X* | X* |
| •* | • | SMR Bone screws | Ti6Al4V | | X |
A= Anatomic / R=Reverse
*NOTE :
- In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder . Replacement, is intended for use with bone cement and should be used without bone screws.
- o The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
- In the US the SMR TT Metal Back Baseplate used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws; while when used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
- If a SMR Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient can be revised by removing the polyethylene baseplate, leaving the metal peg in place and by connecting it to the SMR Hybrid Reverse Baseplate. The SMR Hybrid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation.
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#### K172456
- . The Dia. 50, 52 and 54 mm Humeral Heads with + 3mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric). The Dia. 52 and 54 mm Humeral Heads with + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).
## Delta TT Acetabular System
#### Indications for Use
The Delta TT Acetabular System is 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 and hip dysplasia;
- . Rheumatoid arthritis;
- Post-traumatic arthritis, ●
- Correction of functional deformity;
Fractures, dislocation of the hip and unsuccessful cup arthroplasty. .
Revisions in cases of good remaining bone stock.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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## 510(k) Summary
Date: September 06, 2017 Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant Phone: 260-645-0327 FAX: +39 0432945512
| Product | Product Code | Regulation and Classification Name |
|-------------------------|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bone<br>Screws<br>6.5mm | LPH | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented<br>prosthesis per 21 CFR 888.3358. Device Class: II |
| | MBL | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented<br>prosthesis per 21 CFR 888.3358. Device Class: II |
| | LZO | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous<br>uncemented prosthesis per 21 CFR 888.3353. Device Class: II |
| | PHX | Shoulder joint metal/polymer semi-constrained cemented prosthesis per 21 CFR<br>888.3660. Device Class: II |
| | MBF | Shoulder joint metal/polymer/metal non constrained or semi-constrained porous-<br>coated uncemented prosthesis per 21 CFR 888.3670. Device Class: II |
## Description
Bone screws are used to provide further stability to the Delta TT acetabular cups and to the metal back glenoid of the SMR Shoulder System in reverse shoulder configuration.
The Delta TT acetabular cups (K112898, K141395) are acetabular components intended for uncemented fixation; screw holes present in the Delta TT cups allow optional additional fixation of the cup to the bone using 6.5mm diameter bone screws.
The SMR Shoulder System metal back glenoids (K110598, K113254, K133349, K161120, K163397) are components intended to be implanted into a hole drilled in the glenoid cavity. The metal back glenoid can be used in both anatomic and reverse shoulder configuration; when used in reverse shoulder configuration, the metal back glenoid are intended for uncemented use and are fixed to the glenoid bone through the use of 6.5mm bone screws.
The current submission is for additional lengths of 6.5mm diameter bone screws:
- the proposed range of bone screws used in combination with the SMR Shoulder System is 20mm to 55mm in length;
- the proposed range of bone screws used in combination with the Delta TT Acetabular System is 15mm to 90mm in length.
Design, material, manufacturing process and intended use of the new 6.5mm diameter bone screws are the same as those for the 6.5mm bone screws cleared in the previous 510(k)s.
Special 510(k) - Bone Screws 6.5mm September 06, 2017
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Intended Use/Indications: the additional lengths of 6.5mm bone screws have the same indication for use as the joint replacement system with which they are used. Indications for use of the Delta TT Acetabular System (K112898, K141395) and the indications for use of the SMR Shoulder System (K110598, K113254, K133349, K161120, K163397) are provided below.
## Indications for use Delta Acetabular System (K112898. K141395)
The Delta TT Acetabular System is 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 and hip dysplasia; X
- X Rheumatoid arthritis:
- Post-traumatic arthritis, X
- Correction of functional deformity; X
- Fractures, dislocation of the hip and unsuccessful cup arthroplasty. X
- Revisions in cases of good remaining bone stock. X
# Indications for use SMR Shoulder System (K110598, K113254, K133349, K161120, K163397)
The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement. The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:
- X non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- inflammatory degenerative joint disease such as rheumatoid arthritis; X
- treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation X methods:
- x revision of a failed primary implant;
- cuff tear arthropathy (CTA Heads only); X
- glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification X (SMR Hybrid Glenoid only).
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Hybrid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
Special 510(k) - Bone Screws 6.5mm Sentember 06, 2017
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The Anatomic glenoid construct consists of an all polyethylene glenoid, a polyethylene glenoid with metal peg or a metal back assembled with a liner; the Reverse glenoid consists of a metal back/connector/glenosphere construct or of a peg/baseplate/glenosphere construct.
On the glenoid side, the fixation of the all polyethylene glenoid, the polyethylene glenoid with metal peg or the metal back determines if the construct is cemented or uncemented.
| System | | | | Use | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------------------------------------------------------|-------------------|-----|------------|
| A | R | Components | Material | Cem | Not<br>Cem |
| X | X | SMR Stems (Cemented, Cemented Revision) | Ti6Al4V | X | |
| X | X | SMR Stems (Cementless Finned, Cementless<br>Revision) | Ti6Al4V | | X |
| X | | SMR Humeral Bodies (Trauma, Finned) | Ti6Al4V | X | X |
| X | X | SMR Reverse Humeral Body | Ti6Al4V | X | X |
| X | X | Humeral Extension | Ti6Al4V | X | X |
| X | | SMR Humeral Heads (Standard, CTA) | CoCrMo | X | X |
| X | | SMR Adaptor Tapers (Neutral, Eccentric) | Ti6Al4V | X | X |
| X | | SMR CTA Head Adaptor for Reverse Humeral<br>Body | Ti6Al4V | X | X |
| | X | SMR Glenospheres | CoCrMo | | X |
| | X | SMR Connectors | Ti6Al4V | | X |
| | X | Reverse Liners | UHMWPE | X | X |
| X | | SMR Cemented Glenoids | UHMWPE | X | |
| X | | SMR 3 Pegs Cemented Glenoids | UHMWPE | X | |
| X | X * | SMR Hybrid Glenoid | UHMWPE+Ti6Al4V+Ta | X | X |
| | X | SMR Hybrid Reverse Baseplate + Screw | Ti6Al4V | | X |
| X | X | SMR Metal Back Glenoids | Ti6Al4V+PoroTi | X* | X* |
| X | X | SMR TT Metal Back Baseplate | Ti6Al4V | X* | X* |
| X | X | SMR TT Metal Back Peg | Ti6Al4V | X | X |
| X | | SMR Metal Back Liner | UHMWPE | X* | X* |
| X * | X | SMR Bone screws | Ti6Al4V | | X |
| Material Standards<br>Ti6Al4V (ISO 5832-3 - ASTM F1472) - CoCrMo (ISO 5832-12 - ASTM F1537) – UHMWPE (ISO<br>5834-2 - ASTM F648) - PoroTi Titanium Coating (ASTM F1580) - Ta (ISO13782 - ASTM F560) | | | | | |
#### A= Anatomic / R=Reverse
*NOTE :
- In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic X Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.
- The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR X Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
- In the US the SMR TT Metal Back Baseplate used as part of the SMR Anatomic Shoulder X Replacement, is intended for use with bone cement and should be used without bone screws; while when used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
- If a SMR Hybrid Glenoid is in place and revision to a reverse prosthesis is required, the patient can X
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be revised by removing the polyethylene baseplate. leaving the metal peg in place and by connecting it to the SMR Hybrid Reverse Baseplate. The SMR Hybrid Reverse Baseplate is intended for uncemented use with the addition of screws for fixation.
The Dia. 50, 52 and 54 mm Humeral Heads with + 3mm increased height cannot be x coupled to the Long Adaptor Tapers (both concentric and eccentric). The Dia. 52 and 54 mm Humeral Heads with + 2mm increased height cannot be coupled to the Long Adaptor Tapers (both concentric and eccentric).
## Predicate Devices
Delta TT Acetabular System (Limacorporate, K112898, K141395) SMR Shoulder System (Limacorporate, K110598, K113254, K133349, K161120, K163397) Continuum Acetabular System (Zimmer, K091508) Comprehensive Reverse Shoulder System (Biomet, K080642, K113121) Aequalis PerFORM Reversed (Tornier, K161742) ReUnion RSA Shoulder System (Stryker, K161863)
## Comparable Features to Predicate Device(s)
The new lengths of 6.5mm bone screws are identical in design, diameter, material, manufacturing process, packaging, sterilization, intended use, and indications for use to the 6.5mm bone screws cleared in K112898, K141395, K113254, K133349, K161120 and K 163397; the only difference is that the new bone screws provide shorter and longer lengths.
The indications for use for the additional lengths of 6.5mm bone screws are the same as the indications for use the previously cleared 6.5mm bone screws and the same as those of the systems with which they are used, either the Delta TT Acetabular System or SMR Shoulder System.
## Non-Clinical Testing:
The additional lengths of 6.5mm bone screws use the same fundamental scientific technology and device design concepts, are made from the same materials utilizing the same manufacturing processes, utilize the same packaging and sterilization processes, and have the same indications for use as the predicate devices; the new lengths of 6.5mm diameter bone screws therefore do not require any testing to determine substantial equivalency.
LAL testing is performed, according to Limacorporate sampling and testing program, to establish that the subject device meets the pyrogen limit specification of 20EU/device.
## Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the new sizes of bone screws to the predicate devices.
