510(k) · Cleared
ClearedIntersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed Implantes, Ltda · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jun 10, 2015 as substantially equivalent to K083661 (Stryker Corp., 2009) and 9 other predicates after a 175-day review. Its family tree reaches back 10 generations to 1984.
- Decided
- Jun 10, 2015
- Review
- 175 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 10 generations to K841189 (1984). 42 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 6 generations between
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK143572 Intersomatic Cervical Device - DICOM PEEK, Intersomatic…Osteomed Implantes, Ltda · 2015
Show all 10 generations
- Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 5 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 4 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 3 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 2 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 1 generation backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- This deviceK143572 Intersomatic Cervical Device - DICOM PEEK, Intersomatic…Osteomed Implantes, Ltda · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −9 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −8 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −7 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −5 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −4 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −3 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −2 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −1 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| 0 (this device) | K143572 | Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space… | Osteomed Implantes, Ltda | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K083661 | Avs TL Peek SpacersSummary page 4…MAX CFR Section 21 CFR section 888.3080 Device Panel Orthopedic Primary Predicate Stryker Spine AVS® TL PEEK Spacer (K083661) Device Zimmer, BAK/C Vista Interbody Fusion (P980048 S3) Spinal Elements, Cryst… | 2009 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 4…Orthopedic Primary Predicate Stryker Spine AVS® TL PEEK Spacer (K083661) Device Zimmer, BAK/C Vista Interbody Fusion (P980048 S3) Spinal Elements, Crystal Cervical/Lucent Straight Interbody Cages K071724/K07… | 2001 |
| * | K071724 | LucentSummary page 4…Zimmer, BAK/C Vista Interbody Fusion (P980048 S3) Spinal Elements, Crystal Cervical/Lucent Straight Interbody Cages K071724/K073351/K081968) Secondary Predicate LDR Spine Cervical Interbody Fusion System (K091088) Devices SeaSpine, P… | 2007 |
| * | K073351 | CrystalSummary page 4…mmer, BAK/C Vista Interbody Fusion (P980048 S3) Spinal Elements, Crystal Cervical/Lucent Straight Interbody Cages K071724/K073351/K081968) Secondary Predicate LDR Spine Cervical Interbody Fusion System (K091088) Devices SeaSpine, Pacifica… | 2008 |
| * | K081968 | Modification to LucentSummary page 4…K/C Vista Interbody Fusion (P980048 S3) Spinal Elements, Crystal Cervical/Lucent Straight Interbody Cages K071724/K073351/K081968) Secondary Predicate LDR Spine Cervical Interbody Fusion System (K091088) Devices SeaSpine, Pacifica Cage (K0… | 2008 |
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 4…ts, Crystal Cervical/Lucent Straight Interbody Cages K071724/K073351/K081968) Secondary Predicate LDR Spine Cervical Interbody Fusion System (K091088) Devices SeaSpine, Pacifica Cage (K082310) DePuy, Brantigan I/F Cage (P960025)… | 2009 |
| * | K082310 | Hollywood, Pacifica, Redondo, VenturaSummary page 4…K071724/K073351/K081968) Secondary Predicate LDR Spine Cervical Interbody Fusion System (K091088) Devices SeaSpine, Pacifica Cage (K082310) DePuy, Brantigan I/F Cage (P960025) Surgical Dynamic, Ray Threaded Lumbar Fusion… | 2008 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 4…ate LDR Spine Cervical Interbody Fusion System (K091088) Devices SeaSpine, Pacifica Cage (K082310) DePuy, Brantigan I/F Cage (P960025) Surgical Dynamic, Ray Threaded Lumbar Fusion Cage (P950019) Meditech Advisors, T… | 1999 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 4…SeaSpine, Pacifica Cage (K082310) DePuy, Brantigan I/F Cage (P960025) Surgical Dynamic, Ray Threaded Lumbar Fusion Cage (P950019) Meditech Advisors, Talos PLIF (K090707)… | 1996 |
| * | K090707 | Talos Intervertebral Body Fusion DeviceSummary page 4…, Brantigan I/F Cage (P960025) Surgical Dynamic, Ray Threaded Lumbar Fusion Cage (P950019) Meditech Advisors, Talos PLIF (K090707) K143572… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 42 ancestors have a recall of any class.
- 14 other devices also cite its predicate K083661.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The Intersomatic Cervical Device - DICOM PEEK is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-C3 disc to the C7-Tl disc). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with additional supplemental fixation systems…
Read the full statement (222 words)
The Intersomatic Cervical Device - DICOM PEEK is intended for anterior interbody spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-C3 disc to the C7-Tl disc). Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended for use with additional supplemental fixation systems and autogenous bone graft implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with intervertebral cage.
The Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK and Intersomatic Transforaminal - TLIF PEEK is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). DIMEI and TLIF Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The DIMEI and TLIF Spinal Implant is to be used with additional supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143572: Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143572
Report an extraction error
Are you the manufacturer?
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