K090841 · Ulrich GmbH & Co. KG · MQP · Oct 5, 2009 · Orthopedic
Device Facts
Record ID
K090841
Device Name
ADDPLUS
Applicant
Ulrich GmbH & Co. KG
Product Code
MQP · Orthopedic
Decision Date
Oct 5, 2009
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3060
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The AddPlus™ is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The AddPlus™ is intended to be used with supplemental internal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedical screw and rod systems, anterior plate systems, and anterior screw and rod systems. The use of bone grafting material with the AddPlus™ is optional.
Device Story
AddPlus™ is an adjustable, cylindrical titanium alloy cage for vertebral body replacement in thoracolumbar spine (T1-L5). Device bridges intervertebral space to lengthen anterior column, realign spinal profile, and support bone graft consolidation. Features attached fixation plates to prevent migration and subsidence. Available in 12 mm diameter with various expansion ranges and angles. Includes locking, osmium™, and cancellous bone screws for fixation. Implanted by surgeons in clinical settings; requires supplemental internal fixation (e.g., pedicle screw/rod systems). Output is structural stabilization of the spine. Benefits patient by restoring anterior column integrity following tumor or trauma.
Clinical Evidence
Bench testing only. Mechanical testing performed in accordance with FDA guidance 'Guidance for Spinal Systems 510(k)s' (May 2004) to demonstrate capability to withstand anticipated in vivo loads.
Technological Characteristics
Material: Medical grade titanium alloy. Form factor: Adjustable cylindrical cage (12 mm diameter) with fixation plates. Components: Locking screw, osmium™ screw (monocortical), cancellous bone screw (bicortical). Configuration: 4 expansion ranges (13-65 mm) and 4 angles (0°-18°).
Indications for Use
Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma-induced collapse, damage, or instability. Must be used with supplemental internal fixation systems.
Regulatory Classification
Identification
A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
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# 510(k) SUMMARY
This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87
OCT - 5 2009
Establishment Registration Number:
9612420
Merle Symes
President and CEO ulrich medical USA 754 Spirit 40 Park Drive Chesterfield, MO 63005
28 September 2009
ulrich GmbH & Co. KG Buchbrunnenweg 12 89081 Ulm, Germany
Address of Manufacturer:
Contact Person:
Date Prepared:
Trade or Proprietary Name:
AddPlus™, Anterior Distraction Device Plus
Common or Usual Name:
Classification Name:
Spinal intervertebral body fixation orthosis (21 CFR 888.3060)
Vertebral body replacement device
Product code: MQP
Class II
Predicate Device Identification:
VBR™ (K012254)
Device Description:
The AddPlus™ is a modification of the 12 mm diameter VBR™ device cleared under K012254. It is an adjustable (distractable) cylindrical cage with attached fixation plates that add supplemental bilateral spinal fixation to the design of the marketed VBR™ device. The device remains constructed from medical grade titanium alloy. In the case of resected vertebral bodies
Company Confidential
Page 13 of 84
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of the human spine, the AddPlus™ is used for bridging the intervertebral space and serves to lengthen the anterior column, realigning the spinal profile, to stabilize the anterior column, and to support the consolidation of inserted bone material.
The attached fixation plates serve to provide further fixation and stabilization and to prevent migration as well as possible sinking in of the implant. The device is available in one diameter (i.e., 12 mm), four expansion ranges (i.e., 13 - 18 mm, 17 - 26 mm, 25 - 41 mm, and 40 - 65 mm), and four angles (i.e., 0°, 6°, 12°, and 18°).
Available components to be used with the AddPlus™ include a locking screw, osmium™ screw. and cancellous bone screw. The locking screw is used to fix the height of the adjusted AddPlus™4. The osmium™ screw is used for monocortical fixation. It is available in lengths of 14, 16, and 18 mm, with a diameter of 5 mm. The cancellous bone screw is used for bicortical fixation. It is available in lengths of 12, 14, 16, 18, 20, 24, and 26 mm, with a diameter of 4 mm. In addition to these device components, a number of surgical instruments are available for use during implantation of the device.
## Intended use and comparison to predicate devices:
The AddPlus™ is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture).
The AddPlus™ is intended to be used with supplemental internal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedical screw and rod systems, anterior plate systems, and anterior screw and rod systems.
The use of bone grafting material with the AddPlus™ is optional.
## Technological characteristics and comparison to predicate devices:
A comparison of the subject and predicate devices identified technical differences in geometrical configurations. Similarity was noted with regards to material of construction.
The differences in technological characteristics between the subject and predicate devices do not raise new types of safety or effectiveness questions. Accepted scientific methods, such as performance (bench) testing, do exist for assessing the effect of the differences in characteristics.
## Summary of performance data:
Mechanical testing, in accordance with applicable recommendations of FDA guidance titled "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s," dated May 2004, was conducted to demonstrate equivalence to the predicate devices and demonstrated the subject device's capability to withstand anticipated in vivo loads.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ulrich GmbH & Company KG % Ulrich Medical USA Mr. Merle Symes President and Chief Executive Officer 754 Spirit 40 Park Drive Chesterfield, Missouri 63005
OCT - 5 2009
Re: K090841
Trade/Device Name: AddPlus™, Anterior Distraction Device Plus Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: September 28, 2009 Received: September 29, 2009
Dear Mr. Symes:
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 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
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#### Page 2 - Mr. Merle Symes
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known): K090841
Device Name: AddPlus™, Anterior Distraction Device Plus
Indications for Use:
The AddPlus™ is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture).
The AddPlus™ is intended to be used with supplemental internal fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. Such systems include posterior pedical screw and rod systems, anterior plate systems, and anterior screw and rod systems.
The use of bone grafting material with the AddPlus™ is optional.
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## Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use: (21 CFR 807 Subpart C)
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090841
Company Confidential
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.
