K071016 · DePuy Orthopaedics, Inc. · FTM · Sep 4, 2007 · General, Plastic Surgery
Device Facts
Record ID
K071016
Device Name
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
Applicant
DePuy Orthopaedics, Inc.
Product Code
FTM · General, Plastic Surgery
Decision Date
Sep 4, 2007
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.3300
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The DePuy Restore Orthobiologic Soft Tissue Implant is intended to reinforce soft tissue where weakness exists, specifically for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patella, Achilles, biceps, quadriceps, and other tendons. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. The DePuy Restore Orthobiologic Soft Tissue Implant is also intended for use during general tissue reconstruction of the periosteum. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.
Device Story
Resorbable surgical mesh scaffold; manufactured from porcine small intestinal submucosa (SIS) consisting of collagen and water. Supplied as sterile sheets or strands. Used by surgeons during tendon repair or periosteum reconstruction to reinforce weakened soft tissue. Device acts as a scaffold for host tissue ingrowth; replaced by patient's own tissue over time. Does not provide primary biomechanical strength; requires sutures or bone anchors for structural support. Used in clinical/surgical settings.
Clinical Evidence
Bench testing only. Evidence includes biocompatibility testing, viral inactivation testing, and mechanical testing to demonstrate suitability for soft tissue reinforcement.
Technological Characteristics
Material: Porcine small intestinal submucosa (SIS) (collagen/water). Form factor: Sterile sheets or strands. Resorbable scaffold. No electronic or software components.
Indications for Use
Indicated for reinforcement of soft tissue where weakness exists, specifically for tendon repair surgery (rotator cuff, patellar, Achilles, biceps, quadriceps, and others) and general tissue reconstruction of the periosteum. Not intended to replace body structure or provide full mechanical strength for tendon repair; requires concurrent use of sutures or bone anchors.
Regulatory Classification
Identification
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
{0}------------------------------------------------
510(k) Premarket Notification DePuv Restore Orthobiologic Soft Tissue Implant
K07/016
Page ① of ②
#### 510(k) SUMMARY 7.0
NAME OF SPONSOR:
Depuy Orthopaedics, Incorporated 700 Orthopaedic Drive Warsaw, Indiana 46581
510(k) CONTACT: Kathy Harris Director of Regulatory Affairs
SEP - 4 2007
DATE: March 30, 2007
TRADE NAME: DePuy Restore Orthobiologic Soft Tissue Implant COMMOM NAME: Surgical Mesh 21 CFR §878.3300, Class II CLASSIFICATION: PRODUCT CODE: FTM
#### SUBSTANTIALLY EQUIVALENT DEVICES:
- DePuy Restore Orthobiologic Soft Tissue Implant (K031969) .
- CryoLife ProPatch Soft Tissue Repair Matrix (K061892) .
- W.L. Gore Absorbable Mesh (K033671) .
### DEVICE DESCRIPTION AND INTENDED USE:
The DePuy Restore Orthobiologic Soft Tissue Implant is manufactured from porcine small intestinal submucosa (SIS), comprised predominantly of water and collagen, and will be supplied in a sheet or strand configuration in sterile form in a sealed double pouch system.
The DePuy Restore Orthobiologic Soft Tissue Implant is intended to reinforce soft tissue where weakness exists, specifically for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patella, Achilles, biceps, quadriceps, and other tendons. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. The DePuy Restore Orthobiologic Soft Tissue Implant is also intended for use during general tissue reconstruction of the periosteum. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.
#### BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Restore Orthobiologic Soft Tissue Implant is substantially equivalent to the above listed devices (K031969, K061892, K033671) in that it is manufactured from the same material (SIS) as K031969, and has the same intended use and similar indications as K031969, K061892, and K033671, raising no new types of safety and effectiveness questions.
#### DISCUSSION OF TESTS AND TEST RESULTS:
The DePuy Restore Orthobiologic Soft Tissue Implant met the requirements of extensive biocompatibility testing, viral inactivation testing, and mechanical testing, demonstrating suitability for use.
{1}------------------------------------------------
510(k) Premarket Notification DePuy Restore Orthobiologic Soft Tissue Implant
page ② of ②
## CONCLUSIONS DRAWN FROM TESTS:
Outcomes from the evaluation of the DePuy Restore Orthobiologic Soft Tissue Implant provide evidence of its suitability for use in soft tissue repair and substantial equivalency to predicate devices in terms of intended use and technological characteristics.
# 0000019
は
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc % Ms. Kathy Harris Director Regulatory Affairs 700 Orthopaedic Drive PO Box 988 Warsaw, IN 46581-0988
SEP - 4 2007
Re: K071016
Trade/Device Name: DePuy Restore Orthobiologic Soft Tissue Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: August 10, 2007 Received: August 13, 2007
Dear Ms. Harris:
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.
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
{3}------------------------------------------------
Page 2 - Mr. Stephen Meade
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. 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) 276-0115. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Neil R. Oslin
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page ① of ①
### Indications for Use Form
510(k) Number (if known):
Device Name: DePuy Restore Orthobiologic Soft Tissue Implant
#### Indications For Use:
The DePuy Restore Orthobiologic Soft Tissue Implant is intended to reinforce soft tissue where weakness exists, specifically for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, and other tendons. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. The DePuy Restore Orthobiologic Soft Tissue Implant is also intended for use during general tissue reconstruction of the periosteum. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neilson Odlum
Page 1 of 1
(Division Sign-Off) Division of General. Restorative, and Neurological Devices
**510(k) Number** K071016
000029
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.
