K973381 · Innovasive Devices, Inc. · MAI · Feb 18, 1998 · Orthopedic
Device Facts
Record ID
K973381
Device Name
BIOROC EZ SUTURE BONE FASTENER
Applicant
Innovasive Devices, Inc.
Product Code
MAI · Orthopedic
Decision Date
Feb 18, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3030
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The 2.8mm and 3.5mm BioROC EZ Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications: SHOULDER - Repair of rotator cuff tears 1. - Capsular instability 2. - Slap lesion repair 3. - Acromio-clavicular separation 4. - Capsule shift/capsulolabral reconstruction ડ. - Biceps tenodesis ર્. - Deltoid repair 7. KNEE - Extra-capsular repairs, and reattachment of medial collateral ligament, lateral ligament, ﻨﺴ posterior oblique ligament, joint capsule closure. - Patellar ligament and tendon avuision repairs. 2. - 3. Extra-capsular reconstruction, ITB tenodesis ANKLE - 1. Lateral instability - Medial instability 2. - 3. Achilles tendon reconstruction and repair - 4. Mid-foot reconstructions FOOT - 1. Hallux valgus reconstruction ELBOW - 1. Tennis elbow repair - Biceps tendon reattachment 2. - Medial and lateral repairs 3.
Device Story
BioROC EZ Suture Bone Fastener is a sterile, single-use implant for soft tissue-to-bone fixation. Device consists of L-PLA shear pin, expander, and sleeve. During deployment, expander is drawn into sleeve via shear pin, causing sleeve to expand and engage surrounding bone; shear pin then breaks off. Used in open or arthroscopic procedures by surgeons. Instrumentation includes reusable stainless steel drill, drill guide, obturator, deployment handle, and hole finder. Provides mechanical fixation for various orthopedic repairs. Benefits include secure soft tissue reattachment to bone.
Clinical Evidence
No clinical data. Evidence consists of bench testing (bone model holding strength comparison) and animal testing to confirm device efficacy and functional performance.
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
Predicate Devices
Innovasive Devices ROC EZ Suture Bone Fastener (2.8mm and 3.5mm)
Bio-Anchor (Linvatec)
Submission Summary (Full Text)
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## 510(K) SUMMARY
g73381
FEB 1 8 1998
# 1. SUBMITTER:
Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229
Contact: Stephen M. Page, Manager of Regulatory Affairs Date Prepared: December 10, 1997
# 2. DEVICE:
Innovasive 2.8mm and 3.5mm BioROC EZ Suture Bone Fastener Classification Name: Single/multiple component bone fixation appliances and accessories. Trade Name: Innovasive Devices BioROC EZ Suture Bone Fastener
# 3. PREDICATE DEVICE:
The predicate devices used to determine substantial equivalence for the Innovasive Devices BioROC EZ Suture Bone Fastener were (1) the 2.8mm and 3.5mm Innovasive Devices ROC EZ Suture Bone Fastener marketed by Innovasive Devices, Marlborough, MA, and (2) the Bio-Anchor marketed by Linvatec, Largo, FL.
# 4. DEVICE DESCRIPTION:
The BioROC EZ suture bone fastener implant tip portion consists of a shear pin, expander and sleeve. The expander and sleeve is fitted onto the shear pin component such that the expander component is located below the sleeve on the shear pin. As the shear pin is pulled up during the device deployment, the expander engages the sleeve. The expander is tapered such that it will fit into the sleeve component as the deployment action progresses. As the expander is drawn into the sleeve expands to make contact with the surrounding bone. This expanding sleeve results in the final fixation properties of the device. Once the expander is completely seated inside the sleeve, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole.
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In addition to the Fastener, a stainless steel drill and drill guide is available to establish the proper hole in the bone for the Fastener along with an obturator, deployment handle and hole finder. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose.
The Fastener will be available as a sterile, single use device in both an open and arthroscopic version. Both sutured and sutureless versions will be marketed.
## 5. INTENDED USE:
The 2.8mm and 3.5mm BioROC EZ Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications:
#### SHOULDER
- Repair of rotator cuff tears 1.
- Capsular instability 2.
- Slap lesion repair 3.
- Acromio-clavicular separation 4.
- Capsule shift/capsulolabral reconstruction ડ.
- Biceps tenodesis ર્.
- Deltoid repair 7.
#### KNEE
- Extra-capsular repairs, and reattachment of medial collateral ligament, lateral ligament, ﻨﺴ posterior oblique ligament, joint capsule closure.
- Patellar ligament and tendon avuision repairs. 2.
- 3. Extra-capsular reconstruction, ITB tenodesis
#### ANKLE
- 1. Lateral instability
- Medial instability 2.
- 3. Achilles tendon reconstruction and repair
- 4. Mid-foot reconstructions
#### FOOT
- 1. Hallux valgus reconstruction
#### ELBOW
- 1. Tennis elbow repair
- Biceps tendon reattachment 2.
- Medial and lateral repairs 3.
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# 6. COMPARISON OF CHARACTERISTICS:
The existing Innovasive Devices ROC EZ Suture Bone Fastener is comprised of two polymer components, high density polyethylene and acetyl plastic. This device is used to secure a suture in a predrilled hole in bone. It remains fixed in the bone through radial compression as the device is deployed. This remains true for all sizes of the device.
The BioROC EZ device is comprised of L-PLA. As with the predicate device, the BioROC EZ uses an expander fitted on a shear pin which is drawn up into an expandable sleeve. The sleeve expands as the expander is drawn up into it. The shear pin then shears resulting in the device being fixed into the bone site.
## 7. PERFORMANCE DATA:
The following performance data was provided in support of the substantial equivalence determination:
- 1. Bone Model Testing: Comparison of the ultimate holding strength in a bone model compared to the predicate device. The Innovasive BioROC EZ Suture Bone Fastener holding strength was found to be equivalent to the strength of the predicate device.
- 2. Animal Testing: The testing demonstrated the efficacy of the Innovasive BioROC EZ Suture Bone Fastener and confirmed that the device functions adequately to meet its intended use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1998
Mr. Stephen M. Page Manager of Regulatory Affairs Innovasive Devices, Inc. 734 Forest Street 01752 Marlborough, Massachusetts
K973381 Re: Innovasive 2.8mm and 3.5mm Trade Name: BioROC™ EZ Suture Bone Fastener Regulatory Class: II MAI and HWC Product Code: Dated: December 10, 1997 December 11, 1997 Received:
Dear Mr. Page:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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-895. A ---------substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register . . Please note .- _ _ _ _ this response to your premarket notification submission does not affect any obligation you might have under sections_531___________________________________________________________________________________________________________________ through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Stephen M. Page
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
a M. Witten, Ph.D., M.D. Celli Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# INDICATIONS FOR USE 2.8mm/3.5mm BioROC EZ
# SHOULDER
- Bankart repair Repair of rotator cuff tears Capsular instability Slap lesion repair Acromio-clavicular separation Capsule shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair
## KNEE
Extra-capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis.
## ANKLE
Lateral and medial instability Achilles tendon reconstruction and repair Mid-foot reconstructions.
# FOOT
Hallux valgus reconstruction
## ELBOW
Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs
**Prescription Use**
**(Per 21 CFR 801.109)**
colefo
(Division Sign-On)
Division of General Restorative Devices
510(k) Number K97338/
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
