510(k) · Cleared
Recalled · Class II · 2013Issys LP Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Custom Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on May 5, 2011 as substantially equivalent to K070281 (Custom Spine, Inc., 2007) and 7 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it. It has been recalled once.
- Decided
- May 5, 2011
- Review
- 15 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 8
Its longest line of descent runs back 5 generations to K955348 (1996). 15 ancestors in all, the oldest K933881 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 4 generations backK964024 Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 1997
- 3 generations backK992168 Moss Miami 6.35MM Polyaxial ScrewDepuyacromed · 1999
- 2 generations backK022623 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed · 2002
- 1 generation backK072866 Issys LP Spinal Fixation SystemCustom Spine, Inc. · 2007 · Recalled
- This deviceK111099 Issys LP Spinal Fixation SystemCustom Spine, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK113361 Securis Spinal FixationCumtom Spine · 2012
Most influential descendants
Showing 1 of 1 · See all- K113361Securis Spinal FixationCumtom Spine · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −4 | K964024 | Depuy Motech Titanium Moss Miami Spinal System | Depuy, Inc. | 1997 | — |
| −3 | K992168 | Moss Miami 6.35MM Polyaxial Screw | Depuyacromed | 1999 | — |
| −2 | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System) | Depuyacromed | 2002 | — |
| −1 | K072866 | Issys LP Spinal Fixation System | Custom Spine, Inc. | 2007 | 1 |
| 0 (this device) | K111099 | Issys LP Spinal Fixation System | Custom Spine, Inc. | 2011 | — |
| +1 | K113361 | Securis Spinal Fixation | Cumtom Spine | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070281 | Issys LP Spinal Fixation SystemSummary page 1…m Device Classification: Class Ill Regulation Number: 21 CFR 888.3070 Device Product Codes: NKB, KWP, MNI, MNH, KWQ Predlicate Devices ISSYS LP Spinal Fixation System (K070281, K072866) Moss Miami Spinal System (K933881, K955348, K(964024, K983583,1K022623) Optima Spinal System (K03 1585) lDescription… | 2007 |
| * | K072866 | Issys LP Spinal Fixation SystemSummary page 1…Classification: Class Ill Regulation Number: 21 CFR 888.3070 Device Product Codes: NKB, KWP, MNI, MNH, KWQ Predlicate Devices ISSYS LP Spinal Fixation System (K070281, K072866) Moss Miami Spinal System (K933881, K955348, K(964024, K983583,1K022623) Optima Spinal System (K03 1585) lDescription of Modifi… | 2007 |
| * | K933881 | Depuy Motech Moss-Miami Spinal SystemSummary page 1…n Number: 21 CFR 888.3070 Device Product Codes: NKB, KWP, MNI, MNH, KWQ Predlicate Devices ISSYS LP Spinal Fixation System (K070281, K072866) Moss Miami Spinal System (K933881, K955348, K(964024, K983583,1K022623) Optima Spinal System (K03 1585) lDescription of Modified Device The subject ISSYS LP Spin… | 1994 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 1…21 CFR 888.3070 Device Product Codes: NKB, KWP, MNI, MNH, KWQ Predlicate Devices ISSYS LP Spinal Fixation System (K070281, K072866) Moss Miami Spinal System (K933881, K955348, K(964024, K983583,1K022623) Optima Spinal System (K03 1585) lDescription of Modified Device The subject ISSYS LP Spinal Fixati… | 1996 |
| * | K964024 | Depuy Motech Titanium Moss Miami Spinal SystemSummary page 1….3070 Device Product Codes: NKB, KWP, MNI, MNH, KWQ Predlicate Devices ISSYS LP Spinal Fixation System (K070281, K072866) Moss Miami Spinal System (K933881, K955348, K(964024, K983583,1K022623) Optima Spinal System (K03 1585) lDescription of Modified Device The subject ISSYS LP Spinal Fixation System… | 1997 |
| * | K983583 | Depuy Acromed Moss and Moss Miami Spinal SystemsSummary page 1…vice Product Codes: NKB, KWP, MNI, MNH, KWQ Predlicate Devices ISSYS LP Spinal Fixation System (K070281, K072866) Moss Miami Spinal System (K933881, K955348, K(964024, K983583,1K022623) Optima Spinal System (K03 1585) lDescription of Modified Device The subject ISSYS LP Spinal Fixation System includes… | 1998 |
| * | K022623 | 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Summary page 1…uct Codes: NKB, KWP, MNI, MNH, KWQ Predlicate Devices ISSYS LP Spinal Fixation System (K070281, K072866) Moss Miami Spinal System (K933881, K955348, K(964024, K983583,1K022623) Optima Spinal System (K03 1585) lDescription of Modified Device The subject ISSYS LP Spinal Fixation System includes will incl… | 2002 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 1…KWQ Predlicate Devices ISSYS LP Spinal Fixation System (K070281, K072866) Moss Miami Spinal System (K933881, K955348, K(964024, K983583,1K022623) Optima Spinal System (K03 1585) lDescription of Modified Device The subject ISSYS LP Spinal Fixation System includes will include auxiliary connectors in the… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113361 | Securis Spinal Fixation | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 28, 2013 | Class II | Z-1819-2013 | Process control | On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K113361 (Cumtom Spine, 2012) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K070281.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of…
Read the full statement (307 words)
The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
The ISSYS LP Spinal Fixation System is also intended to provide immobilization and stabilization of the spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion of degenerative disc disease and spondylolisthesis other than severe spondylolisthesis (grade 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurological impairment.
When used as non pedicular fixation system:
The ISSYS LP Spinal Fixation System, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:
* Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
* Spondylolisthesis
* Fracture
* Spinal deformities such as scoliosis, kyphosis, lordosis
* Tumor
* Revision of failed fusion attempts
* Pseudoarthrosis
* Spinal Stenosis
When used in the anterior indication the ISSYS LP Spinal Fixation System is indicated for use in the thoracic and lumbar spine.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111099: Issys LP Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111099
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026