K955768 · Bioscience, Inc. · MAI · Mar 4, 1996 · Orthopedic
Device Facts
Record ID
K955768
Device Name
BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM
Applicant
Bioscience, Inc.
Product Code
MAI · Orthopedic
Decision Date
Mar 4, 1996
Decision
SN
Submission Type
Traditional
Regulation
21 CFR 888.3030
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The BIOFIX® Meniscus Arrow System is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (e.g., “red-red” and “red-white” area) in conjunction with appropriate immobilization.
Device Story
BIOFIX® Meniscus Arrow System provides arthroscopic fixation for longitudinal vertical meniscus lesions. Device consists of self-reinforced poly-L-lactide (SR-PLLA) arrow with cylindrical shaft, barbs, and T-shaped head. Implanted via specialized stainless steel instruments (cannulae, obturator, drill/needle, piston) using standard arthroscopic portals. Device stabilizes meniscus during healing; degrades via hydrolysis into lactic acid over 20-50 weeks. Used by orthopedic surgeons in clinical settings. Output is mechanical stabilization of meniscal tissue; facilitates healing by maintaining proximity of torn tissue to periphery. Benefits include reduced operative time and effective fixation compared to traditional suturing.
Clinical Evidence
Prospective, randomized, controlled trial comparing BIOFIX® Meniscus Arrows to inside-out arthroscopic suturing (Maxon-0). N=68 (34 per group). Primary endpoint: healing at 12 weeks. Results: 26/32 (81%) healed in BIOFIX group vs 17/31 (55%) in suture group (p=0.032). Functional scores comparable at 12 weeks, 6 months, and 1 year. No deep/superficial infections in BIOFIX group; 4 infections reported in suture group. Study concludes BIOFIX is at least as effective as sutures with reduced operative time.
Technological Characteristics
Material: Self-reinforced poly-L-lactide (SR-PLLA). Form factor: Cylindrical shaft (1.1 mm diameter) with barbs and T-shaped head (1.0 x 1.1 x 3.5 mm). Lengths: 10, 13, 16 mm. Energy source: None (mechanical fixation). Sterilization: Supplied sterile. Implantation: Requires medical grade stainless steel instruments (cannulae, obturator, drill/needle, piston). Degradation: Hydrolytic, non-enzymatic.
Indications for Use
Indicated for patients with longitudinal vertical meniscus lesions (bucket-handle lesions) in the vascularized (red-red or red-white) area of the meniscus requiring arthroscopic fixation.
Regulatory Classification
Identification
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.
Acufex Microsurgical, Inc. T-Fix Suture Bar (K925573)
Acufex Microsurgical, Inc. implantation instruments (K942442)
Submission Summary (Full Text)
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K955768
MAR - 4 1996
K 955768
510(k) SUMMARY
BIOSCIENCE, INC.
BIOFIX® Biodegradable Meniscus Arrow System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Jonathan S. Kahan, Esq.
Hogan & Hartson L.L.P.
555 13th Street, N.W.
Washington, D.C. 20004-1109
Phone: (202) 637-5794
Facsimile: (202) 637-5910
as Regulatory Counsel to Bioscience, Inc.
Contact Person: same as above
Date Prepared: December 20, 1995
Name of Device and Name/Address of Sponsor
BIOFIX® Biodegradable Meniscus Arrow System
Bioscience, Inc.
279 B Great Valley Parkway
Malvern, PA 19355
Classification Name
Bioabsorbable orthopedic fixation device
Predicate Devices
Davis & Geck Maxon Monofilament Polyglyconate Synthetic Absorbable Surgical Sutures (PMA G840051) (Maxon sutures)
Acufex Microsurgical, Inc. T-Fix Suture Bar (K925573) and implantation instruments (K942442) (T-Fix Meniscus Fixation System)
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# Intended Use
The BIOFIX® Meniscus Arrow System is intended for arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (e.g., “red-red” and “red-white” area) in conjunction with appropriate immobilization.
# Technological Characteristics and Substantial Equivalence
BIOFIX® Meniscus Arrows are bioabsorbable orthopedic fixation devices composed of self-reinforced poly-L-lactide (SR-PLLA). They possess physical and chemical properties necessary for secure fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (e.g., “red-red” and “red-white” area) in combination with suitable immobilization. The surgically implanted BIOFIX® Meniscus Arrows lose strength over 20 to 50 weeks in vivo; within a corresponding period of time, the meniscus rupture is healed. The implant material degrades by hydrolysis rather than by enzymatic action. The degradation product is lactic acid, a normal body metabolite, that is readily eliminated as carbon dioxide during respiration.
The BIOFIX® Meniscus Arrow consists of a cylindrical shaft with barbs in one end and a T-shaped head at the other end. The barbs assure that the shaft is kept in place in the capsule and the peripheral part of the meniscus, while the T-shaped head keeps the loose part of the meniscus in close proximity to the periphery. The device has a shaft diameter of 1.1 mm and is available in lengths of 10 mm, 13 mm, and 16 mm. The dimensions of the T-shaped head are 1.0 mm x 1.1 mm x 3.5 mm. A specially designed set of application instruments, made of medical grade stainless steel, are required for implantation of BIOFIX® Meniscus Arrows. The set consists of six cannulae, a blunt obturator, a small drill or needle, and a piston.
The BIOFIX® Meniscus Arrow System is substantially equivalent to two predicate devices: (1) Davis & Geck’s Maxon sutures, approved under PMA
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G840051; and (2) Acufex Microsurgical's T-Fix Suture Bar and implantation instruments (T-Fix Meniscus Fixation System), cleared under K925573 and K942442. The BIOFIX® Meniscus Arrow System is substantially equivalent to these predicate devices in that its intended use is a use subsumed within the broader indication of the Maxon sutures for soft tissue approximation and within the broader indication of the T-Fix Meniscus Fixation System for meniscal repair, and in that BIOFIX® Meniscus Arrows and its predicate devices are designed to stabilize the meniscus during the healing period.
The BIOFIX® Meniscus Arrow System, like the two predicate devices, uses standard arthroscopic portals for implantation. Both the BIOFIX® Meniscus Arrow System and the T-Fix Meniscus Fixation System are implanted with precise delivery instruments. Both BIOFIX® Meniscus Arrows and Maxon sutures are absorbed by the body, unlike the T-Fix device which is permanent unless removal is necessary because of an adverse situation.
BIOFIX® Meniscus Arrows, like the predicate devices, are supplied sterile and require good surgical technique and proper postoperative immobilization.
Although there are some differences in materials and implantation instruments and technique between the BIOFIX® Meniscus Arrows and its predicate devices, no new issues of safety and efficacy have been raised.
## Nonclinical and Clinical Testing
### Nonclinical Testing
Mechanical testing was carried out to determine the initial separation force between the head and shaft of the arrow and the initial pull-out force of the barbs on the arrow shaft, and these same properties under *in vitro* hydrolytic conditions that simulate the hydrolytic degradation of the BIOFIX® Meniscus Arrow *in vivo*. These results and the results of the clinical study described below demonstrated that the arrows possess sufficient strength for the period needed for healing and stabilization of the fixation site.
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# Clinical Testing
Arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) with BIOFIX® Meniscus Arrows was compared in a prospective, randomized, controlled trial to inside-out arthroscopic suturing with the Acufex Double Barrel System using Maxon-0 sutures. Patients returned for evaluation at two weeks, five weeks, nine weeks, 12 weeks, six months, and at one year following surgery. Complete healing was defined as healing in the full length of the former rupture, while partial healing was defined as a residual rupture of less than 10 mm in an otherwise stable meniscus.
Thirty-four patients were enrolled in each treatment group. Of the 32 patients in the BIOFIX® Meniscus Arrow group for whom 12 week healing assessment results were available, 26 were found to have healed lesions, three to have partially healed, stable lesions, two to have partially healed, unstable lesions, and one to have an unhealed lesion. Of the 31 patients in the suture group for whom 12 week healing assessment results were available, 17 were found to have healed lesions, seven to have partially healed, stable lesions, two to have partially healed, unstable lesions, and five to have an unhealed lesion. Results were also analyzed for each treatment group by length of tear, distance from joint capsule to lesion, and operative location of meniscal tear. When the “healed” versus “not healed” results were grouped, there was a statistically significant difference in favor of the BIOFIX® Meniscus Arrow group (p = 0.032).
Knee function scores were analyzed for each treatment group at the 12 week, six month, and one year visits; scores were comparable in the two groups at each assessment. In addition, patients evaluated their own status at the follow-up visits and rated their status as “excellent,” “acceptable,” or “unacceptable.” There were no significant differences in the number of excellent or acceptable assessments at any visit in the two groups, nor in the number of unacceptable assessments.
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There were no deep or superficial infections related to meniscal repair in the BIOFIX® Meniscus Arrow group, nor were there any serious neurological problems. There were two deep infections in the suture group and two cases of superficial infection related to meniscal repair in the suture group; no serious neurological problems were reported in this group.
In summary, BIOFIX® Meniscus Arrows were shown to be at least as good as sutures in the treatment of bucket-handle lesions. In this study, operative time was considerably less, more lesions were healed 12 weeks postoperatively, and there were fewer meniscal repair-related complications in the BIOFIX® Meniscus Arrow group than in the suture group, while functional results were comparable.
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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.
