510(k) · Cleared
ClearedPrime BIOFOAM® Multi-Hole Shells
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Cleared on Aug 24, 2021 as substantially equivalent to K170444 (Microport Orthopedics, Inc., 2017) and 2 other predicates after a 481-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Aug 24, 2021
- Review
- 481 days
- Class
- Class II
- Product code
- MBL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K930712 (1993). 21 ancestors in all, the oldest K864626 (1986). No later device cites it as a predicate yet.
- Root · 7 generations backK930712 P.F.C. Total Hip System Porous Coated ModularJohnson & Johnson Orthopaedics, Inc. · 1993
- 6 generations backK983014 Summit Acetabular SystemJohnson & Johnson Professionals, Inc. · 1998
- 5 generations backK000306 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000 · Recalled
- 4 generations backK001534 Pinnacle Acetabular SystemDePuy Orthopaedics, Inc. · 2000
- 3 generations backK071784 Depuy Pinnacle with Gripton Acetabular CupsDePuy Orthopaedics, Inc. · 2007
- 2 generations backK090998 Depuy Pinnacle 100 with Gription Acetabular CupsDePuy Orthopaedics, Inc. · 2009
- 1 generation backK170444 PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017
- This deviceK201157 Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930712 | P.F.C. Total Hip System Porous Coated Modular | Johnson & Johnson Orthopaedics, Inc. | 1993 | — |
| −6 | K983014 | Summit Acetabular System | Johnson & Johnson Professionals, Inc. | 1998 | — |
| −5 | K000306 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | 1 |
| −4 | K001534 | Pinnacle Acetabular System | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K071784 | Depuy Pinnacle with Gripton Acetabular Cups | DePuy Orthopaedics, Inc. | 2007 | — |
| −2 | K090998 | Depuy Pinnacle 100 with Gription Acetabular Cups | DePuy Orthopaedics, Inc. | 2009 | — |
| −1 | K170444 | PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics, Inc. | 2017 | — |
| 0 (this device) | K201157 | Prime BIOFOAM® Multi-Hole Shells | Microport Orthopedics, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 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 MBL? 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 MBL device
- #1 K201701 R3 HA Coated Acetabular Shellsscore 1.3 · 5 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K170444 | PROCOTYL® PRIME Acetabular Cup SystemSummary page 4…II Subject Panel and Orthopedics/87/MBL, LPH, LZO Product Code(s): Legally Marketed Devices to which Substantial Equivalence is claimed: Primary Predicate: K170444 Prime Acetabular Cup System MicroPort Orthopedics Inc. Predicate Devices: K122382 DYNASTY® BIOFOAM® Shell… | 2017 |
| * | K122382 | Dynasty Biofoam ShellSummary page 4…s to which Substantial Equivalence is claimed: Primary Predicate: K170444 Prime Acetabular Cup System MicroPort Orthopedics Inc. Predicate Devices: K122382 DYNASTY® BIOFOAM® Shell MicroPort Orthopedics Inc. K082924 DYNASTY® BIOFOAM® Shell… | 2012 |
| * | K082924 | Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal…Summary page 4…Cup System MicroPort Orthopedics Inc. Predicate Devices: K122382 DYNASTY® BIOFOAM® Shell MicroPort Orthopedics Inc. K082924 DYNASTY® BIOFOAM® Shell MicroPort Orthopedics Inc.… | 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 28 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 4 of the 21 ancestors have a recall of any class.
- 7 other devices also cite its predicate K170444.
How does its category compare?
All MBL devicesMBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · MBL
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MBL
Too few MBL 510(k)s in any year since 2007 to give a median.
Recalls per year · MBL
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBL
41in 2025
MAUDE reports naming product code MBL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 2 | 6 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 0 | — | 0 | 55 |
| 2016 | 1 | — | 0 | 54 |
| 2017 | 0 | — | 0 | 61 |
| 2018 | 1 | — | 0 | 112 |
| 2019 | 0 | — | 0 | 172 |
| 2020 | 1 | — | 0 | 115 |
| 2021 | 1 | — | 0 | 116 |
| 2022 | 0 | — | 0 | 90 |
| 2023 | 0 | — | 0 | 78 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Prime Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use
1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2) inflammatory degenerative joint disease such as rheumatoid arthritis;
3) correction of functional deformity; and,
4) revision procedures where other treatments or devices have failed.
Shells with BIOFOAM® coating are intended only for uncemented arthroplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201157 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201157: Prime BIOFOAM® Multi-Hole Shells.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201157
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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